- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03809182
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
September 9, 2020 updated by: Eduardo Vega, Pontificia Universidad Catolica de Chile
Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Other Names:
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:
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:
|
Placebo Comparator: 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.
|
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:
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:
The same infusion rate used in the dexmedetomidine group.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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).
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Since the beginning of anesthesia until the end of it, an average of one hour and a half.
|
Amount (mg) of Morphine Consumed.
Time Frame: At 24h postoperative hours.
|
Morphine consumption in the first 24 postoperative hours.
|
At 24h postoperative hours.
|
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.
|
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.
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).
|
At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).
|
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.
|
Postoperative nausea and vomiting during the first 12 postoperative hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Mauricio Ibacache, MD, PhD, Pontificia Universidad Catolica de Chile
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2012
Primary Completion (Actual)
July 25, 2013
Study Completion (Actual)
July 25, 2013
Study Registration Dates
First Submitted
December 30, 2018
First Submitted That Met QC Criteria
January 17, 2019
First Posted (Actual)
January 18, 2019
Study Record Updates
Last Update Posted (Actual)
October 1, 2020
Last Update Submitted That Met QC Criteria
September 9, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Hyperinsulinism
- Hyperglycemia
- Glucose Intolerance
- Insulin Resistance
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Fentanyl
- Dexmedetomidine
- Morphine
Other Study ID Numbers
- Dexmedetomidine and glycemia.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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