Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809182
• Other study ID #: Dexmedetomidine and glycemia.
• Status: Completed
• Phase: Phase 4
• Start date: September 27, 2012
• Est. completion date: July 25, 2013

Study information

• Verified date: September 2020
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 25, 2013
• Est. primary completion date: July 25, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Glucose Intolerance
• Insulin Resistance

Intervention

Drug:
• Dexmedetomidine
A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
• 0.9% Sodium-chloride
The same infusion rate used in the dexmedetomidine group.
• 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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fentanyl Consumption.	Amount of fentanyl (ug/kg) intraoperatively administered.	Since the beginning of anesthesia until the end of it, an average of one hour and a half.
Secondary	Amount (mg) of Morphine Consumed.	Morphine consumption in the first 24 postoperative hours.	At 24h postoperative hours.
Secondary	Pain Scores in the First 24 Postoperative Hours.	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.	At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).
Secondary	Sedation-agitation Scores in the First 12 Postoperative Hours.	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).	At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).
Secondary	Postoperative Nausea and Vomiting.	Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.	Postoperative nausea and vomiting during the first 12 postoperative hours.