Clinical trial NCT03809182: Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
Official title: Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Glucose Intolerance
Insulin Resistance
Keywords: Impaired Glucose Tolerance
Obese patients
Dexmedetomidine
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, placebo-controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Plasmatic Glucose Levels (mg/dl).
timeFrame: 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
measure: Plasmatic Insulin Levels (uU/ml).
timeFrame: 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:
measure: Fentanyl Consumption.
timeFrame: Since the beginning of anesthesia until the end of it, an average of one hour and a half.
measure: Amount (mg) of Morphine Consumed.
timeFrame: At 24h postoperative hours.
measure: Pain Scores in the First 24 Postoperative Hours.
timeFrame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).
measure: Sedation-agitation Scores in the First 12 Postoperative Hours.
timeFrame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).
measure: Postoperative Nausea and Vomiting.
timeFrame: Postoperative nausea and vomiting during the first 12 postoperative hours.
Other outcomes:
Locations:
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Mauricio Ibacache, MD, PhD
role: STUDY_DIRECTOR
References: