Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

NCT ID: NCT03809182

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-27
• Study Completion Date: 2013-07-25

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.

Conditions

Bariatric Surgery Candidate; Glucose Intolerance; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.

Fentanyl

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

0.9% Sodium-chloride

Intervention Type: DRUG

The same infusion rate used in the dexmedetomidine group.

Fentanyl

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

Dexmedetomidine

A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.

Intervention Type: DRUG

0.9% Sodium-chloride

The same infusion rate used in the dexmedetomidine group.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Precedex; Normal saline; Sublimaze; Morphine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Vega

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauricio Ibacache, MD, PhD

Role: STUDY_DIRECTOR

Pontificia Universidad Catolica de Chile

Other Identifiers

Dexmedetomidine and glycemia.

Identifier Type: -

Identifier Source: org_study_id