Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

• Sponsor: Pontificia Universidad Catolica de Chile (Other)
• Overall Status: Completed
• CT.gov ID: NCT03809182
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Actual Duration (Months): 9.9

Study Details

Study Description

Brief Summary

This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate; Glucose Intolerance; Insulin Resistance	Drug: Dexmedetomidine; Drug: 0.9% Sodium-chloride; Drug: Fentanyl; Drug: Morphine Sulfate	Phase 4

Detailed Description

A prospective, double-blind, randomized controlled trial was performed. Consenting obese adult patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded as secondary outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, randomized, placebo-controlled trialProspective, randomized, placebo-controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Blinded
• Primary Purpose: Treatment
• Official Title: Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.
• Actual Study Start Date: Sep 27, 2012
• Actual Primary Completion Date: Jul 25, 2013
• Actual Study Completion Date: Jul 25, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.	Drug: Dexmedetomidine; A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.; Other Names: Precedex ; Drug: Fentanyl; Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).; Other Names: Sublimaze ; Drug: Morphine Sulfate; Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.; Other Names: Morphine
Placebo Comparator: 0.9% Sodium-chloride After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.	Drug: 0.9% Sodium-chloride; The same infusion rate used in the dexmedetomidine group.; Other Names: Normal saline ; Drug: Fentanyl; Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).; Other Names: Sublimaze ; Drug: Morphine Sulfate; Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.; Other Names: Morphine

Outcome Measures

Primary Outcome Measures

1. Plasmatic Glucose Levels (mg/dl). [Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine]

   Change of baseline glucose levels within the first 12 postoperative hours.

2. Plasmatic Insulin Levels (uU/ml). [Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine]

   Change of baseline insulin levels within the first 12 postoperative hours.

Secondary Outcome Measures

1. Fentanyl Consumption. [Since the beginning of anesthesia until the end of it, an average of one hour and a half.]

   Amount of fentanyl (ug/kg) intraoperatively administered.

2. Amount (mg) of Morphine Consumed. [At 24h postoperative hours.]

   Morphine consumption in the first 24 postoperative hours.

3. Pain Scores in the First 24 Postoperative Hours. [At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).]

   Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.

4. Sedation-agitation Scores in the First 12 Postoperative Hours. [At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).]

   Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).

5. Postoperative Nausea and Vomiting. [Postoperative nausea and vomiting during the first 12 postoperative hours.]

   Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Obese patient (BMI>30)

• American Society of Anesthesiologists grades II or III

• Diagnosis of impaired glucose tolerance

• Undergoing sleeve gastrectomy

Exclusion Criteria:

• Baseline glucose > 200mg/dl

• Diagnosis of Diabetes

• Under corticosteroids treatment

• Oral hypoglycemic medication within 7 days previous surgery

• Use of insulin within 24h previous surgery

• Allergy to any drug used in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pontificia Universidad Catolica de Chile

Investigators

• Study Director: Mauricio Ibacache, MD, PhD, Pontificia Universidad Catolica de Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eduardo Vega, Instructor, Pontificia Universidad Catolica de Chile
• ClinicalTrials.gov Identifier: NCT03809182
• Other Study ID Numbers: Dexmedetomidine and glycemia.
• First Posted: Jan 18, 2019
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Keywords provided by Eduardo Vega, Instructor, Pontificia Universidad Catolica de Chile: Impaired Glucose Tolerance; Obese patients; Dexmedetomidine
• Additional relevant MeSH terms: Insulin Resistance; Glucose Intolerance; Fentanyl; Dexmedetomidine; Morphine

Study Results

Participant Flow

Recruitment Details	The patients were recruited at the Pontifical Catholic University Hospital between 2012 and 2013. Twenty patients were assigned to each arm to allow some dropouts. Nonetheless, every randomized patient included in the study was analyzed at the end of it (intention to treat analysis).
Pre-assignment Detail	No patient was excluded from the study after being assigned to one arm/group.

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group received: Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.	After anesthesia induction, patients who were randomized to the Placebo group received: 0.9% Sodium-chloride: The same bolus and infusion rate used in the dexmedetomidine group. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride	Total
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room.	After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. 0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room.	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	20 100%	40 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33 (10.2)	31.5 (9.9)	32 (10)
Sex: Female, Male (Count of Participants)
Female	20 100%	15 75%	35 87.5%
Male	0 0%	5 25%	5 12.5%
Region of Enrollment (participants) [Number]
Chile	20 100%	20 100%	40 100%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	34.4 (2.5)	35.2 (3.6)	34.8 (3.1)
ASA physical status II (Count of Participants)
Count of Participants [Participants]	20 100%	20 100%	40 100%
Risk score for postoperative nausea and vomiting (PONV) in adults (Count of Participants)
0 risk factor	0 0%	0 0%	0 0%
1 risk factor	0 0%	4 20%	4 10%
2 risk factors	14 70%	9 45%	23 57.5%
3 risk factors	5 25%	6 30%	11 27.5%
4 risk factors	1 5%	1 5%	2 5%
Baseline HbA1c (Percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage]	5.4 (0.2)	5.4 (0.4)	5.4 (0.3)

Outcome Measures

1. Primary Outcome

Title	Plasmatic Glucose Levels (mg/dl).
Description	Change of baseline glucose levels within the first 12 postoperative hours.
Time Frame	Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine

Outcome Measure Data

Analysis Population Description

All recruited population was analyzed.

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group received: Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.	After anesthesia induction, patients who were randomized to the Placebo group received: 0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Measure Participants	20	20
Baseline level (T0)	80 (15)	82 (8)
Hour 2 (T1)	114 (29)	111 (20)
Hour 4 (T2)	124 (25)	129 (17)
Hour 6 (T3)	131 (60)	120 (16)
Hour 8 (T4)	122 (41)	118 (17)
Hour 10 (T5)	130 (62)	117 (18)
Hour 12 (T6)	125 (31)	117 (17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexmedetomidine, 0.9% Sodium-chloride
	Comments	Null hypothesis: There is no difference in plasmatic glucose levels between dexmedetomidine and 0.9% sodium-chloride groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments	A p-value less than .05 was considered statistically significant.
	Method	Mixed Models Analysis
	Comments

2. Primary Outcome

Title	Plasmatic Insulin Levels (uU/ml).
Description	Change of baseline insulin levels within the first 12 postoperative hours.
Time Frame	Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.	After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. 0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Measure Participants	20	20
Baseline level (T0)	10.5 (6)	11.2 (6)
Hour 2 (T1)	11.8 (9)	19.9 (11.8)
Hour 4 (T2)	16.7 (9.5)	30.3 (19.9)
Hour 6 (T3)	16.8 (11.4)	23 (11.4)
Hour 8 (T4)	16.6 (8.9)	21.5 (10.4)
Hour 10 (T5)	16 (10)	24 (17.7)
Hour 12 (T6)	16.6 (9.2)	25.9 (18.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexmedetomidine, 0.9% Sodium-chloride
	Comments	Null hypothesis: There is no difference in insulin levels between dexmedetomidine and 0.9% sodium-chloride groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	A p-value less than .05 was considered statistically significant.
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Fentanyl Consumption.
Description	Amount of fentanyl (ug/kg) intraoperatively administered.
Time Frame	Since the beginning of anesthesia until the end of it, an average of one hour and a half.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.	After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. 0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Measure Participants	20	20
Mean (Standard Deviation) [mcg/kg]	6.0 (2.2)	7 (2.4)

4. Secondary Outcome

Title	Amount (mg) of Morphine Consumed.
Description	Morphine consumption in the first 24 postoperative hours.
Time Frame	At 24h postoperative hours.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.	After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. 0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Measure Participants	20	20
Mean (Standard Deviation) [mg]	26 (14.4)	18.4 (10.6)

5. Secondary Outcome

Title	Pain Scores in the First 24 Postoperative Hours.
Description	Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.
Time Frame	At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.	After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. 0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Measure Participants	20	20
Hour 2 (T1) Pain at rest	0	0
Hour 2 (T1) Pain at movement	0	0
Hour 4 (T2) Pain at rest	4	3
Hour 4 (T2) Pain at movement	5	4
Hour 6 (T3) Pain at rest	3	2
Hour 6 (T3) Pain at movement	4	4
Hour 8 (T4) Pain at rest	3	1
Hour 8 (T4) Pain at movement	4	4
Hour 10 (T5) Pain at rest	3	1
Hour 10 (T5) Pain at movement	5	3
Hour 12 (T6) Pain at rest	3	1
Hour 12 (T6) Pain at movement	3	3
Hour 24 (T7) Pain at rest	2	0
Hour 24 (T7) Pain at movement	3	3

6. Secondary Outcome

Title	Sedation-agitation Scores in the First 12 Postoperative Hours.
Description	Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).
Time Frame	At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.	After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. 0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Measure Participants	20	20
Hour 2 (T1)	3	4
Hour 4 (T2)	4	4
Hour 6 (T3)	4	4
Hour 8 (T4)	4	4
Hour 10 (T5)	4	4
Hour 12 (T6)	4	4

7. Secondary Outcome

Title	Postoperative Nausea and Vomiting.
Description	Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.
Time Frame	Postoperative nausea and vomiting during the first 12 postoperative hours.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.	After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. 0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Measure Participants	20	20
Count of Participants [Participants]	16 80%	19 95%

Adverse Events

Time Frame	Intraop and 24 hours post-surgery.
Adverse Event Reporting Description	Record of vital signs was written in the anesthesia sheet. Non-serious adverse events were presented as follow: Hypotension Bradycardia Hypotension associated with bradycardia
Arm/Group Title	Dexmedetomidine		0.9% Sodium-chloride
Arm/Group Description	After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.		After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. 0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion). Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
All Cause Mortality
	Dexmedetomidine		0.9% Sodium-chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Dexmedetomidine		0.9% Sodium-chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Dexmedetomidine		0.9% Sodium-chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/20 (85%)		10/20 (50%)
Cardiac disorders
Isolated hypotension	2/20 (10%)	2	4/20 (20%)	4
Isolated Bradycardia	7/20 (35%)	7	4/20 (20%)	4
Hypotension associated with bradycardia	10/20 (50%)	10	2/20 (10%)	2

Limitations/Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE 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.