search
Back to results

The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial

Primary Purpose

Loss of Consciousness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
normal saline
dexmedetomidine 0.5 µg/kg
dexmedetomidine 1.0 µg/kg
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Loss of Consciousness focused on measuring Propofol, Dexmedetomidine, Dose, Bispectral index monitor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I-II
  • Aged 18-65 years
  • Body Mass Index 18.0～24.5 kg/m2
  • Without hearing impairment

Exclusion Criteria:

  • Bradycardia
  • Atrioventricular block
  • Neurologic disorder and recent use of psychoactive medication
  • Allergic to the drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group control

    Group dexmedetomidine 0.5 µg/kg

    Group dexmedetomidine 1.0 µg/kg

    Arm Description

    24 eligible patients are received equal volumes of saline intravenously for 10 minutes

    24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes

    25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes

    Outcomes

    Primary Outcome Measures

    The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness

    Secondary Outcome Measures

    The bispectral index values when patients loss of consciousness

    Full Information

    First Posted
    May 16, 2016
    Last Updated
    November 6, 2016
    Sponsor
    General Hospital of Ningxia Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02783846
    Brief Title
    The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial
    Official Title
    The Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    General Hospital of Ningxia Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.
    Detailed Description
    It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general anaesthesia. Administration of dexmedetomidine during the preoperative period has been demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine premedication on the propofol dose requirement and bispectral index at loss of consciousness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Loss of Consciousness
    Keywords
    Propofol, Dexmedetomidine, Dose, Bispectral index monitor

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group control
    Arm Type
    Placebo Comparator
    Arm Description
    24 eligible patients are received equal volumes of saline intravenously for 10 minutes
    Arm Title
    Group dexmedetomidine 0.5 µg/kg
    Arm Type
    Active Comparator
    Arm Description
    24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes
    Arm Title
    Group dexmedetomidine 1.0 µg/kg
    Arm Type
    Active Comparator
    Arm Description
    25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes
    Intervention Type
    Other
    Intervention Name(s)
    normal saline
    Intervention Description
    receive equal volume of normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine 0.5 µg/kg
    Intervention Description
    receive dexmedetomidine 0.5 µg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine 1.0 µg/kg
    Intervention Description
    receive dexmedetomidine 1.0 µg/kg
    Primary Outcome Measure Information:
    Title
    The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness
    Time Frame
    To infuse dexmedetomidine and saline completely ten minutes after
    Secondary Outcome Measure Information:
    Title
    The bispectral index values when patients loss of consciousness
    Time Frame
    To infuse dexmedetomidine and saline completely ten minutes after

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA physical status I-II Aged 18-65 years Body Mass Index 18.0～24.5 kg/m2 Without hearing impairment Exclusion Criteria: Bradycardia Atrioventricular block Neurologic disorder and recent use of psychoactive medication Allergic to the drugs

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    safety
    Citations:
    PubMed Identifier
    32334510
    Citation
    Gu Y, Yang F, Zhang Y, Zheng J, Wang J, Li B, Ma T, Cui X, Lu K, Ma H. The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial. BMC Anesthesiol. 2020 Apr 25;20(1):96. doi: 10.1186/s12871-020-01013-x.
    Results Reference
    derived

    Learn more about this trial

    The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial

    We'll reach out to this number within 24 hrs