The Effect of Intraoperative Labetalol on Time to Discharge

Sponsor

Dr. Robert Tanzola (Other)

Overall Status

Completed

CT.gov ID

NCT02997800

Collaborator

(none)

172

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain. Opioids however have many unpleasant side effects including nausea and vomiting, itching, sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood pressure are often attributed to pain. It has been shown that by treating these changes with medications such as esmolol, instead of opioids, side effects and time to discharge from hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have advantages over it. It is more effective at controlling both heart rate and blood pressure and it is easier and less costly to use. This study is investigating labetalol in patients having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients will be treated with one of these drugs during surgery to control heart rate and blood pressure and the effects on time to discharge, pain scores, frequency of side effects, and narcotic requirements will be observed in the recovery room. It is thought that labetalol will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will show reduced time to discharge, fewer side effects, and effective treatment of heart rate and blood pressure.

Condition or Disease	Intervention/Treatment	Phase
Bloodpressure Heart Rate	Drug: Esmolol Drug: Labetalol Drug: Fentanyl Other: saline infusion Other: 1 ml saline infusion	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Intraoperative Labetalol on Time to Discharge and Hemodynamic Stability in Laparoscopic Cholecystectomy

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esmolol Esmolol infusion and 1 ml saline infusion	Drug: Esmolol Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of esmolol 30 mg IV (30 mg in 5 ml of normal saline). An intravenous esmolol infusion will be initiated at 5mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5mcg/kg/min each time HR or MAP >20% of baseline. An intravenous bolus of placebo (normal saline 1 ml) will be administered whenever a change to the infusion rate is made. Other: 1 ml saline infusion Every time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused.
Experimental: Labetalol Labetalol Bolus and saline infusion	Drug: Labetalol Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of labetalol 10 mg IV (10 mg in 5 ml of normal saline). Any further increases in HR or MAP >20% of baseline will be treated with intravenous boluses of labetalol 5 mg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given. Other: saline infusion An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus drug dose (fentanyl or labetalol depending upon randomization) and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.
Active Comparator: Fentanyl Fentanyl Bolus and saline infusion	Drug: Fentanyl Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of fentanyl 50 mcg IV (50 mcg in 5 ml of normal saline). Any further increases in HR or MAP >20% of baseline will be treated with intravenous boluses of fentanyl 25 mcg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given. Other: saline infusion An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus drug dose (fentanyl or labetalol depending upon randomization) and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.

Arm

Intervention/Treatment

Experimental: Esmolol

Esmolol infusion and 1 ml saline infusion

Drug: Esmolol

Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of esmolol 30 mg IV (30 mg in 5 ml of normal saline). An intravenous esmolol infusion will be initiated at 5mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5mcg/kg/min each time HR or MAP >20% of baseline. An intravenous bolus of placebo (normal saline 1 ml) will be administered whenever a change to the infusion rate is made.

Other: 1 ml saline infusion

Every time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused.

Experimental: Labetalol

Labetalol Bolus and saline infusion

Drug: Labetalol

Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of labetalol 10 mg IV (10 mg in 5 ml of normal saline). Any further increases in HR or MAP >20% of baseline will be treated with intravenous boluses of labetalol 5 mg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.

Other: saline infusion

An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus drug dose (fentanyl or labetalol depending upon randomization) and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.

Active Comparator: Fentanyl

Fentanyl Bolus and saline infusion

Drug: Fentanyl

Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of fentanyl 50 mcg IV (50 mcg in 5 ml of normal saline). Any further increases in HR or MAP >20% of baseline will be treated with intravenous boluses of fentanyl 25 mcg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.

Other: saline infusion

Outcome Measures

Primary Outcome Measures

Length of stay in the post-anesthesia care unit (PACU) [The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).]
time from arrival in PACU after surgery until discharge from PACU

Secondary Outcome Measures

Intraoperative Heart Rate (HR) [intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.]
heart rate (beats per min.)
Intraoperative mean arterial pressure (MAP) [intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.]
blood pressure (mmHg)
postoperative nausea and vomiting (PONV) in PACU [The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).]
incidence of nausea and vomiting
pain scores [The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).]
pain scores visual analogue scale (VAS)
fentanyl required [The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).]
total fentanyl required mcg
adverse effects [The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).]
Any reported adverse effects or complications
postoperative heart rate [The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).]
heart rate (beats per min)
postoperative mean arterial pressure (MAP) [The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).]
blood pressure (mmHg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

scheduled to undergo elective ambulatory laparoscopic cholecystectomy under general anesthesia
American Society of Anesthesiologist's Status ASA) 1-3
able to understand and sign informed consent

Exclusion Criteria:

known allergy to any of the study medications including beta blockers, fentanyl, acetaminophen, non-steroidal anti-inflammatories or local anesthetics
chronic use of beta-adrenergic receptor antagonists or opioids
conversion to open cholecystectomy
History of renal, hepatic or cardiac failure, reactive airway disease
Medical history that in the investigator's judgement would interfere with the protocol or assessments
Unable to understand pain assessment
Failure to give informed consent
pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen's University, Department of Anesthesiology	Kingston	Ontario	Canada	K7L 2V7

Sponsors and Collaborators

Dr. Robert Tanzola

Investigators

Principal Investigator: Robert Tanzola, MD, FRCPC, Queen's University-Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Robert Tanzola, Principal Investigator, Queen's University

ClinicalTrials.gov Identifier:

NCT02997800

Other Study ID Numbers:

ANAE-219-12

First Posted:

Dec 20, 2016

Last Update Posted:

Feb 13, 2020

Last Verified:

Feb 1, 2020

Additional relevant MeSH terms:

Labetalol

Fentanyl

Esmolol

Study Results

No Results Posted as of Feb 13, 2020