Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 4

Conditions: Insulin Resistance; Bariatric Surgery Candidate; Glucose Intolerance

Treatments: Drug: 0.9% Sodium-chloride; Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03809182

Dexmedetomidine and glycemia.

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental 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.

Treatment:

Drug: Morphine Sulfate

Drug: Fentanyl

Drug: Dexmedetomidine

0.9% Sodium-chloride

Placebo Comparator group

Description:

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.

Treatment:

Drug: Morphine Sulfate

Drug: Fentanyl

Drug: 0.9% Sodium-chloride