Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

Overview

In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo.

Full Title of Study: “Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2015

Detailed Description

Patients undergoing surgery under general anesthesia may experience several complications during the postoperative period. Shivering has been reported to occur in up to 65% of patients recovering from general anesthesia, and has been shown to cause detrimental effects to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery significantly reduces the incidence of postoperative shivering and improves quality of emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the expense of prolonged time to extubation and awakening. The aim of this study is to find the optimal dose of dexmedetomidine that would be beneficial without delaying recovery from general anesthesia.

Interventions

  • Drug: dexmedetomidine 0.25 µg/kg IV
  • Drug: dexmedetomidine 0.5 µg/kg IV
  • Drug: dexmedetomidine 1 µg/kg IV
  • Drug: Placebo Comparator
    • Patients in Group IV will receive same volume of normal saline at closure of sevoflurane

Arms, Groups and Cohorts

  • Active Comparator: Group I
    • Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane
  • Active Comparator: Group II
    • Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane
  • Active Comparator: Group III
    • Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane
  • Placebo Comparator: Group IV
    • Patients in Group IV will receive same volume of normal saline at closure of sevoflurane

Clinical Trial Outcome Measures

Primary Measures

  • Postanaesthetic shivering incidence and score
    • Time Frame: change from baseline every 10 minutes up to 1 hour post-operatively
  • Quality of emergence from anesthesia
    • Time Frame: Change from baseline every 5 minutes till extubation
    • The anesthesiologist blinded to the group allocation will assess patients for coughing, hypertension, tachycardia, limb movement during extubation

Secondary Measures

  • Patient’s Temperature
    • Time Frame: every 10 minutes up to 1 hour post-operatively
  • Time to extubation, awakening and orientation
    • Time Frame: 1 hour post-operatively
  • Sedation scores
    • Time Frame: every 10 minutes up to 1 hour post-operatively
  • Pain scores
    • Time Frame: every 10 minutes up to 1 hour post-operatively
  • Nausea and vomiting
    • Time Frame: every 10 minutes up to 1 hour post-operatively

Participating in This Clinical Trial

Inclusion Criteria

  • 18-80 year-old
  • ASA class I, II, and III
  • patients undergoing elective surgery under general anesthesia with an estimated time of 1-3 h

Exclusion Criteria

  • duration of surgery less than 1h or more than 3 h
  • allergy to dexmedetomidine
  • vasoactive antidepressant or analgesics
  • obesity (BMI>30)
  • fever
  • pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • American University of Beirut Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Marie Awad, Professor of Clinical Specialty – American University of Beirut Medical Center
  • Overall Official(s)
    • Marie Aouad, MD, Principal Investigator, American Univesity of Beirut Medical Center

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