Clinical Trials Directory

Trials / Completed

CompletedNCT03809182

Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Pontificia Universidad Catolica de Chile · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDexmedetomidineA bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
DRUG0.9% Sodium-chlorideThe same infusion rate used in the dexmedetomidine group.
DRUGFentanylIntraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
DRUGMorphine SulfateBoluses 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.

Timeline

Start date
2012-09-27
Primary completion
2013-07-25
Completion
2013-07-25
First posted
2019-01-18
Last updated
2020-10-01
Results posted
2020-10-01

Source: ClinicalTrials.gov record NCT03809182. Inclusion in this directory is not an endorsement.