Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01114971
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Actual Duration (Months): 106.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study proposes to investigate the effects of labetalol or esmolol on managing the vital signs (like blood pressure and heart rate) during surgery, on pain management, and on the later recovery after surgery.

It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Surgery	Drug: Fentanyl; Drug: Labetalol; Drug: Esmolol	Phase 4

Detailed Description

Finding the optimal combination of anesthetic adjuvant drugs for maintaining hemodynamic stability during surgery is a challenge (1-3). Traditionally, potent opioid analgesics like fentanyl and its newer analogs have been used for this purpose. However, use of opioid compounds is associated with well-known side effects (e.g., ventilatory depression, postoperative nausea and vomiting, constipation, ileus, bladder dysfunction, urinary retention, pruritus, drowsiness and sedation). All of these common side effects interfere with the early recovery process and contribute to a delayed resumption of normal activities (4, 5). Increasingly, non-opioid analgesics (e.g. β-blockers and local anesthetics) are being utilized as adjuvant drugs during surgery for treatment of acute hyperdynamic responses (increased catecholamine release) during surgery, as well as, facilitation of the recovery process after surgery because of their anesthetic and analgesic-sparing effects. The β-blocking drugs, esmolol and labetalol have been used as an alternative to short-acting opioid analgesics for controlling the transient, acute autonomic responses during surgery (5-8), They have been shown to reduce the anesthetic requirement during intravenous (propofol) or volatile-based anesthesia (6,7,10-13) and to decrease opioid consumption intraoperatively and in the PACU (8). They may also improve hemodynamic stability during induction and emergence from anesthesia in the perioperative and early postoperative period and facilitate the resumption of normal activities after major surgical procedures. The anesthetic and analgesic-sparing effects of β -blockers also lead to a faster emergence from anesthesia and reduce postoperative opioid side effects (e.g., PONV) (14-18). Perioperative intravenous esmolol has shown improvement in perioperative outcomes, decreases acute hemodynamic responses, reduces anesthetics and opioids use during anesthesia, facilitates a faster emergence from anesthesia, reduces intraoperative and postoperative opioid requirements, reduces side effects as such as pruritus, constipation, ileus, nausea and vomiting (PONV) and thereby shortens the hospital stay. (3, 7, 13, 18)

Local anesthetics like lidocaine possess analgesic, antihyperalgesic and anti-inflammatory properties. Perioperative intravenous lidocaine has shown improvement in perioperative outcomes in patients undergoing abdominal surgery to decrease intraoperative requirement of Inhalants/Intravenous agents, opioid consumption, postoperative pain, fatigue, nausea and vomiting scores, maintain hemodynamic stability, facilitate a more rapid recovery of gastrointestinal function, improve postoperative recovery, fast resumption of normal activities of daily living and shorten length of hospital stay, when administered as an adjuvant during surgery.(19,23-29,33)

Theoretically, it would be extremely beneficial to administer an adjuvant (to patients undergoing abdominal surgery) that is capable of effectively controlling autonomic responses during surgery, while providing a faster recovery with fewer side effects. Preliminary data suggests that the perioperative effects of systemic administration of lidocaine and esmolol is most effective in facilitating bowel recovery, decreasing opioid consumption in the intra/postoperative period, and shorten length of hospital stay with early recovery. Therefore, we designed this prospective, randomized, double-blinded, active-controlled study to test the hypothesis that systemic administration of lidocaine and esmolol in combination (vs. either drug alone) for maintenance of hemodynamic stability during surgery will result in improved postoperative outcomes for patients undergoing abdominal surgery (e.g., less pain and postoperative nausea and vomiting, and faster return of bowel function and resumption of normal activities of daily living); leading to a shorten length of hospital stay.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Randomized, Double-Blinded, Active-Controlled Study to Evaluate the Intraoperative Use of Labetalol vs. Esmolol for Maintaining Hemodynamic Stability During Laparoscopic Surgery: Effect on Recovery and Postoperative Pain
• Actual Study Start Date: Sep 3, 2009
• Actual Primary Completion Date: Jul 30, 2014
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fentanyl Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm)	Drug: Labetalol; Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Drug: Esmolol; Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Other Names: Brevibloc
Experimental: Labetalol Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Drug: Fentanyl; Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Drug: Esmolol; Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Other Names: Brevibloc
Experimental: Esmolol Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Drug: Fentanyl; Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm); Drug: Labetalol; Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain [one day]

   Postoperative pain will be measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 VRS is a subjective measure in which individuals verbally rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)

Secondary Outcome Measures

1. Number of Participant With Opioid Consumption [1 month]

   n=Post discharge use of opioid consumption NUMBER OF PARTICIPANTS WHO TOOK PAIN KILLER PILLS

2. Postoperative Nausea and Vomiting [1 day]

   Nausea and vomiting will be measured at PACU

3. Return to Feeling Normal [1 month]

   Days to report to return to feeling normal, using follow up questionnaires

4. Patient Satisfaction Using a Verbal Rating Scale From 0 to 10 [1 month]

   Patient satisfaction using a verbal rating scale from 0 to 10 Where a VRS is a subjective measure in which individuals verbally rated their level of satisfaction on an eleven-point numerical scale. The scale is composed of 0 (excellent satisfaction) to 10

5. Low Appetite [1 month]

   Participant who experienced low appetite (follow up questionnaire)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled to undergo outpatient surgery procedures

• Willingness and ability to sign an informed consent document

• No allergies to anesthetic or analgesic medications

• 18 - 80 years of age

• American Society of Anesthesiologists (ASA) physical status classification I - III adults of either sex

• Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test

Exclusion Criteria:

• Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications

• Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders

• Pregnant or lactating women

• Subjects with a history of alcohol or drug abuse within the past 3 months

• Any other conditions or use of any medication which may interfere with the conduct of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Ronald H Wender, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ronald Wender, Chairman, Department of Anesthesiology, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT01114971
• Other Study ID Numbers: Pro00019328
• First Posted: May 3, 2010
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ronald Wender, Chairman, Department of Anesthesiology, Cedars-Sinai Medical Center: Labetalol; Esmolol; Fentanyl; Anesthetic adjuvant; Ambulatory surgery; Outpatient surgery; Pain management; Hemodynamic stability; Perioperative outcomes
• Additional relevant MeSH terms: Labetalol; Fentanyl; Esmolol

Study Results

Participant Flow

Arm/Group Title	Fentanyl	Labetalol	Esmolol
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Period Title: Overall Study
STARTED	25	25	25
COMPLETED	25	25	25
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Fentanyl	Labetalol	Esmolol	Total
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Total of all reporting groups
Overall Participants	25	25	25	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (13)	42 (14)	49 (11)	46 (13)
Sex: Female, Male (Count of Participants)
Female	21 84%	21 84%	15 60%	57 76%
Male	4 16%	4 16%	10 40%	18 24%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	3 12%	0 0%	1 4%	4 5.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	3 12%	6 24%	4 16%	13 17.3%
White	19 76%	19 76%	19 76%	57 76%
More than one race	0 0%	0 0%	1 4%	1 1.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Postoperative Pain
Description	Postoperative pain will be measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 VRS is a subjective measure in which individuals verbally rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
Time Frame	one day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fentanyl	Labetalol	Esmolol
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Measure Participants	25	25	25
Mean (Standard Deviation) [Score on scale 0-10]	3.2 (2)	3 (3)	3.9 (2.5)

2. Secondary Outcome

Title	Number of Participant With Opioid Consumption
Description	n=Post discharge use of opioid consumption NUMBER OF PARTICIPANTS WHO TOOK PAIN KILLER PILLS
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fentanyl	Labetalol	Esmolol
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Measure Participants	25	25	25
Number [participants]	15 60%	14 56%	13 52%

3. Secondary Outcome

Title	Postoperative Nausea and Vomiting
Description	Nausea and vomiting will be measured at PACU
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fentanyl	Labetalol	Esmolol
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Measure Participants	25	25	25
Number [participants]	9 36%	4 16%	7 28%

4. Secondary Outcome

Title	Return to Feeling Normal
Description	Days to report to return to feeling normal, using follow up questionnaires
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fentanyl	Labetalol	Esmolol
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Measure Participants	25	25	25
Mean (Standard Deviation) [Days]	11 (9)	10 (9)	12 (10)

5. Secondary Outcome

Title	Patient Satisfaction Using a Verbal Rating Scale From 0 to 10
Description	Patient satisfaction using a verbal rating scale from 0 to 10 Where a VRS is a subjective measure in which individuals verbally rated their level of satisfaction on an eleven-point numerical scale. The scale is composed of 0 (excellent satisfaction) to 10
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fentanyl	Labetalol	Esmolol
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Measure Participants	25	25	25
Mean (Standard Deviation) [score on a scale (0-10)]	9.1 (1.6)	9 (1.2)	8 (2.5)

6. Secondary Outcome

Title	Low Appetite
Description	Participant who experienced low appetite (follow up questionnaire)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fentanyl	Labetalol	Esmolol
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
Measure Participants	25	25	25
Number [participants]	15 60%	7 28%	9 36%

Adverse Events

Time Frame	One month
Arm/Group Title	Fentanyl		Labetalol		Esmolol
Arm/Group Description	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)		Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)		Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
All Cause Mortality
	Fentanyl		Labetalol		Esmolol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Fentanyl		Labetalol		Esmolol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Fentanyl		Labetalol		Esmolol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.