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The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia

Primary Purpose

Analgesia, Patient-Controlled, Analgesia, Postoperative

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dexmedetomidine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Analgesia, Patient-Controlled

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients who sign informed consent to receive general anesthesia and postoperative analgesia with a PCA device
  2. Age between 18-65 y/o
  3. ASA physical status I-III
  4. Scheduled surgical procedures: gynecological surgery (vaginal or abdominal total hysterectomy), general surgery (gastrectomy, hepatectomy, colon cancer) , orthopedic (spinal fusion or total knee placement), or neurosurgical (cervical decompression)

Exclusion Criteria:

  1. Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants).
  2. Use of sedatives, analgesics, antiemetics, or antipruritics within 24 hours before operation.
  3. Patients with definite diagnosis of esophageal reflux syndrome.
  4. Patients with the probability to be pregnant.
  5. Intraoperative fentanyl use > 6 μg/kg.
  6. Patients with significant bradycardia (HR < 60/min) and hypotension (SBP < 90mmHg) after the surgery.
  7. The duration of surgery is longer than 6 hours.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2008
    Last Updated
    December 1, 2008
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00800826
    Brief Title
    The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA).
    Detailed Description
    Patient-controlled analgesia (PCA) is a widely accepted method to control postoperative pain. Morphine is the commonest opioid for PCA, however its side effects are troublesome. Morphine-related side effects include pruritus, nausea, vomiting, constipation, urinary retention, respiratory depression, and sedation. Many studies had been conducted to reduce the side effect of morphine. The current trend of reducing morphine side effect is direct combination of other drugs and morphine in PCA. The advantages of this method are convenient in clinical use and preventive for side effects. Dexmedetomidine is a highly selec¬tive α2-adrenergic receptor agonist that has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. The main advantage of this drug is that it does not cause serious respiratory side effects. The analgesic, sedative/hypnotic and anxiolytic prop¬erties of dexmedetomidine make this drug potentially useful for postoperative sedation and analgesia. No previous study had investigated the effect of direct combination of dexmedetomidine and morphine in PCA. The goal of this study is to investigate the combination effect of dexmedetomidine and morphine in postoperative patient-controlled analgesia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia, Patient-Controlled, Analgesia, Postoperative

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine

    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: Patients who sign informed consent to receive general anesthesia and postoperative analgesia with a PCA device Age between 18-65 y/o ASA physical status I-III Scheduled surgical procedures: gynecological surgery (vaginal or abdominal total hysterectomy), general surgery (gastrectomy, hepatectomy, colon cancer) , orthopedic (spinal fusion or total knee placement), or neurosurgical (cervical decompression) Exclusion Criteria: Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants). Use of sedatives, analgesics, antiemetics, or antipruritics within 24 hours before operation. Patients with definite diagnosis of esophageal reflux syndrome. Patients with the probability to be pregnant. Intraoperative fentanyl use > 6 μg/kg. Patients with significant bradycardia (HR < 60/min) and hypotension (SBP < 90mmHg) after the surgery. The duration of surgery is longer than 6 hours.

    12. IPD Sharing Statement

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    The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia

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