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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00800826
First received: December 1, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA).


Condition Intervention Phase
Analgesia, Patient-Controlled
Analgesia, Postoperative
Drug: dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Enrollment: 150
Study Start Date: November 2006
Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00800826     History of Changes
Other Study ID Numbers: 950910
Study First Received: December 1, 2008
Last Updated: December 1, 2008
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014