Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

Phase 4

Completed

Conditions: Bariatric Surgery Candidate
Glucose Intolerance
Insulin Resistance

Interventions: Drug: 0.9% Sodium-chloride
Drug: Dexmedetomidine
Drug: Fentanyl
Drug: Morphine Sulfate

Registration Number: NCT03809182

Lead Sponsor: Pontificia Universidad Catolica de Chile

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% Sodium-chloride	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.
Dexmedetomidine	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.
Dexmedetomidine	Fentanyl	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	Morphine Sulfate	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.
0.9% Sodium-chloride	Fentanyl	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	Morphine Sulfate	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.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
Amount (mg) of Morphine Consumed.	At 24h postoperative hours.	Morphine consumption in the first 24 postoperative hours.
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.
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).
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.