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Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

Primary Purpose

Restlessness, Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dexmedetomidine
saline placebo
Sponsored by
Fang Luo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Restlessness

Eligibility Criteria

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

Inclusion Criteria:

  • American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
  • undergoing selective thoracotomy
  • weight between 45 and 75kg
  • operation time 2-4 hours

Exclusion Criteria:

  • history of neurologic disease
  • history of chronic analgesics intake
  • history of allergic reactions to the experimental durgs
  • history of renal insufficiency
  • history of hepatic dysfunction
  • history of coagulation disorders
  • women in lactation
  • participating in other studies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group-DEX

    Group-PLB

    Arm Description

    Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery

    Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery

    Outcomes

    Primary Outcome Measures

    Emergence agitation
    Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours

    Secondary Outcome Measures

    Postoperative pain at rest
    The patients were instructed to give the number that represented the pain level at rest by using visual analogue scale（VAS）and prince-henry score
    dosage Dosage of analgesics
    Recovery time
    Postoperative sedation
    It was assessed by Ramsay Sedation Score(RSS)
    Extubation time
    Breathing recovery time

    Full Information

    First Posted
    January 22, 2012
    Last Updated
    March 18, 2013
    Sponsor
    Fang Luo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01517932
    Brief Title
    Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia
    Official Title
    Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fang Luo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression. In this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.
    Detailed Description
    Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Restlessness, Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group-DEX
    Arm Type
    Experimental
    Arm Description
    Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery
    Arm Title
    Group-PLB
    Arm Type
    Placebo Comparator
    Arm Description
    Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine
    Intervention Description
    In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction. Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46. Patients in this arm received dexmedetomidine 0.2μg/kg i.v. during 10 minutes 1 hour before the end of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    saline placebo
    Intervention Description
    In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction. Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46. Patients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery
    Primary Outcome Measure Information:
    Title
    Emergence agitation
    Description
    Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours
    Time Frame
    during 0-3 postoperative hours
    Secondary Outcome Measure Information:
    Title
    Postoperative pain at rest
    Description
    The patients were instructed to give the number that represented the pain level at rest by using visual analogue scale（VAS）and prince-henry score
    Time Frame
    At 1,3 postoperative hours
    Title
    dosage Dosage of analgesics
    Time Frame
    during 3 postoperative hours
    Title
    Recovery time
    Time Frame
    At the moment of the eyes opend when calling the names
    Title
    Postoperative sedation
    Description
    It was assessed by Ramsay Sedation Score(RSS)
    Time Frame
    at 0,1,3 postoperative hours
    Title
    Extubation time
    Time Frame
    at the moment of extubation
    Title
    Breathing recovery time
    Time Frame
    when autonomous respiration recovered

    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: American Society of Anaesthesiologists Physical Status (ASA-PS) I or II undergoing selective thoracotomy weight between 45 and 75kg operation time 2-4 hours Exclusion Criteria: history of neurologic disease history of chronic analgesics intake history of allergic reactions to the experimental durgs history of renal insufficiency history of hepatic dysfunction history of coagulation disorders women in lactation participating in other studies
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fang Luo, MD.PhD
    Organizational Affiliation
    Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

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