Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

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

Detailed Description
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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.

Official Title
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Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.

Conditions
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Bariatric Surgery Candidate, Glucose Intolerance, Insulin Resistance

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: 0.9% Sodium-chloride
* Drug: Fentanyl
* Drug: Morphine Sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, placebo-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>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<br>* A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.<br>* Other names: Precedex;Drug: Fentanyl<br>* Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).<br>* Other names: Sublimaze;Drug: Morphine Sulfate<br>* 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.<br>* Other names: Morphine;|
| Placebo Comparator: 0.9% Sodium-chloride<br>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<br>* The same infusion rate used in the dexmedetomidine group.<br>* Other names: Normal saline;Drug: Fentanyl<br>* Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).<br>* Other names: Sublimaze;Drug: Morphine Sulfate<br>* 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.<br>* Other names: Morphine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic Glucose Levels (mg/dl). | Change of baseline glucose levels within the first 12 postoperative hours. | 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 | 
| Plasmatic Insulin Levels (uU/ml). | Change of baseline insulin levels within the first 12 postoperative hours. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl Consumption. | Amount of fentanyl (ug/kg) intraoperatively administered. | Since the beginning of anesthesia until the end of it, an average of one hour and a half. | 
| Amount (mg) of Morphine Consumed. | Morphine consumption in the first 24 postoperative hours. | At 24h postoperative hours. | 
| Pain Scores in the First 24 Postoperative Hours. | 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. | At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7). | 
| Sedation-agitation Scores in the First 12 Postoperative Hours. | 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). | At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6). | 
| Postoperative Nausea and Vomiting. | Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours. | Postoperative nausea and vomiting during the first 12 postoperative hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impaired Glucose Tolerance, Obese patients, Dexmedetomidine