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Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

Primary Purpose

Bariatric Surgery Candidate, Glucose Intolerance, Insulin Resistance

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
0.9% Sodium-chloride
Fentanyl
Morphine Sulfate
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring Impaired Glucose Tolerance, Obese patients, Dexmedetomidine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Dexmedetomidine

    0.9% Sodium-chloride

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Plasmatic Glucose Levels (mg/dl).
    Change of baseline glucose levels within the first 12 postoperative hours.
    Plasmatic Insulin Levels (uU/ml).
    Change of baseline insulin levels within the first 12 postoperative hours.

    Secondary Outcome Measures

    Fentanyl Consumption.
    Amount of fentanyl (ug/kg) intraoperatively administered.
    Amount (mg) of Morphine Consumed.
    Morphine consumption in the first 24 postoperative hours.
    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.
    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).
    Postoperative Nausea and Vomiting.
    Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.

    Full Information

    First Posted
    December 30, 2018
    Last Updated
    September 9, 2020
    Sponsor
    Pontificia Universidad Catolica de Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03809182
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 27, 2012 (Actual)
    Primary Completion Date
    July 25, 2013 (Actual)
    Study Completion Date
    July 25, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pontificia Universidad Catolica de Chile

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bariatric Surgery Candidate, Glucose Intolerance, Insulin Resistance
    Keywords
    Impaired Glucose Tolerance, Obese patients, Dexmedetomidine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, randomized, placebo-controlled trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Blinded
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexmedetomidine
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    0.9% Sodium-chloride
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    Precedex
    Intervention Description
    A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% Sodium-chloride
    Other Intervention Name(s)
    Normal saline
    Intervention Description
    The same infusion rate used in the dexmedetomidine group.
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Other Intervention Name(s)
    Sublimaze
    Intervention Description
    Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine Sulfate
    Other Intervention Name(s)
    Morphine
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Plasmatic Glucose Levels (mg/dl).
    Description
    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
    Title
    Plasmatic Insulin Levels (uU/ml).
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Fentanyl Consumption.
    Description
    Amount of fentanyl (ug/kg) intraoperatively administered.
    Time Frame
    Since the beginning of anesthesia until the end of it, an average of one hour and a half.
    Title
    Amount (mg) of Morphine Consumed.
    Description
    Morphine consumption in the first 24 postoperative hours.
    Time Frame
    At 24h postoperative hours.
    Title
    Pain Scores in the First 24 Postoperative Hours.
    Description
    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.
    Time Frame
    At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).
    Title
    Sedation-agitation Scores in the First 12 Postoperative Hours.
    Description
    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).
    Time Frame
    At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).
    Title
    Postoperative Nausea and Vomiting.
    Description
    Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.
    Time Frame
    Postoperative nausea and vomiting during the first 12 postoperative hours.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mauricio Ibacache, MD, PhD
    Organizational Affiliation
    Pontificia Universidad Catolica de Chile
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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