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Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03809182
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Eduardo Vega, Pontificia Universidad Catolica de Chile

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

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Glucose Intolerance Insulin Resistance Drug: Dexmedetomidine Drug: 0.9% Sodium-chloride Drug: Fentanyl Drug: Morphine Sulfate Not Applicable

Detailed Description:
A prospective, double-blind, randomized controlled trial was performed. Consenting obese adults 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinded
Primary Purpose: Other
Official Title: Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance
Actual Study Start Date : March 1, 2013
Actual Primary Completion Date : February 1, 2014
Actual Study Completion Date : February 1, 2014

Resource links provided by the National Library of Medicine


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/min until the end of surgery. In 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
A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Other Name: Precedex

Drug: 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).
Other Name: Sublimaze

Drug: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.

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 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
The same dose used in the dexmedetomidine group (bolus and infusion).
Other Name: Saline

Drug: 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).
Other Name: Sublimaze

Drug: 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 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.




Primary Outcome Measures :
  1. Change of baseline glucose levels within the first 12 postoperative hours. [ 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 ]
    Glucose levels (mg/dl).

  2. Change of baseline insulin levels within the first 12 postoperative hours. [ 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 ]
    Insulin levels (uU/ml).


Secondary Outcome Measures :
  1. Fentanyl consumption. [ Time Frame: Intraoperative period. ]
    Amount (ug) of fentanyl intraoperatively administered.

  2. Morphine consumption 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). ]
    Amount (mg) of morphine consumed.

  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). ]
    Riker 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. Number of patients with postoperative nausea and vomiting 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). ]
    Postoperative nausea and vomiting.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809182


Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Study Director: Mauricio Ibacache, MD, PhD Pontificia Universidad Catolica de Chile
  Study Documents (Full-Text)

Documents provided by Eduardo Vega, Pontificia Universidad Catolica de Chile:
Study Protocol  [PDF] June 6, 2012
Statistical Analysis Plan  [PDF] June 6, 2012

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Responsible Party: Eduardo Vega, Instructor, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03809182    
Other Study ID Numbers: Dexmedetomidine and glycemia
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Eduardo Vega, Pontificia Universidad Catolica de Chile:
Impaired Glucose Tolerance
Obese patients
Dexmedetomidine
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Fentanyl
Morphine
Dexmedetomidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics