Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

NCT03809182 | Completed Phase 4 Results DMC

• 1 other identifier: Dexmedetomidine and glycemia.
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bariatric Surgery Candidate; Glucose Intolerance; Insulin Resistance

Keywords

Impaired Glucose Tolerance; Obese patients; Dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Fentanyl Consumption.

  Since the beginning of anesthesia until the end of it, an average of one hour and a half.

• Amount (mg) of Morphine Consumed.

  At 24h 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).

• 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).

• Postoperative Nausea and Vomiting.

  Postoperative nausea and vomiting during the first 12 postoperative hours.

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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; Drug: Fentanyl; Drug: Morphine Sulfate

0.9% Sodium-chloride

PLACEBO COMPARATOR

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; Drug: Fentanyl; Drug: Morphine Sulfate

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

0.9% Sodium-chloride DRUG

The same infusion rate used in the dexmedetomidine group.

Also known as: Normal saline

0.9% Sodium-chloride

Fentanyl 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).

Also known as: Sublimaze

0.9% Sodium-chloride; Dexmedetomidine

Morphine Sulfate 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.

Also known as: Morphine

0.9% Sodium-chloride; Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obese patient (BMI\>30)
• American Society of Anesthesiologists grades II or III
• Diagnosis of impaired glucose tolerance
• Undergoing sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Interventions

Dexmedetomidine; Sodium Chloride; Saline Solution; Fentanyl; Morphine

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Piperidines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Mauricio Ibacache MD
• Organization: Pontificia Universidad Católica de Chile

mibacach@med.puc.cl

+56984421425

Study Officials

• Mauricio Ibacache, MD, PhD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: Prospective, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 18, 2019
• Study Start: September 27, 2012
• Primary Completion: July 25, 2013
• Study Completion: July 25, 2013
• Last Updated: October 1, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share