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Completed

NCT Number: NCT03809182

Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

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

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Key information

Conditions

Bariatric Surgery Candidate Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

0.9% Sodium-chloride

Drug

The same infusion rate used in the dexmedetomidine group.

Other names: Normal saline

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).

Other names: Sublimaze

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.

Other names: Morphine

Primary outcomes

  1. Plasmatic Glucose Levels (mg/dl).

    Time frame: 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

    Change of baseline glucose levels within the first 12 postoperative hours.

  2. Plasmatic Insulin Levels (uU/ml).

    Time frame: 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

    Change of baseline insulin levels within the first 12 postoperative hours.

Secondary outcomes

  1. Fentanyl Consumption.

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

    Amount of fentanyl (ug/kg) intraoperatively administered.

  2. Amount (mg) of Morphine Consumed.

    Time frame: At 24h postoperative hours.

    Morphine consumption in the first 24 postoperative hours.

  3. Pain Scores in the First 24 Postoperative Hours.

    Time frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).

    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.

  4. Sedation-agitation Scores in the First 12 Postoperative Hours.

    Time frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).

    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).

  5. Postoperative Nausea and Vomiting.

    Time frame: Postoperative nausea and vomiting during the first 12 postoperative hours.

    Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2019
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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