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The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
This study has been completed.
First Received: December 1, 2008   No Changes Posted
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00800826
  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 IV

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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
No Contacts or Locations Provided
  More Information

No publications provided

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

Study placed in the following topic categories:
Morphine
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Analgesics, Non-Narcotic
Hypnotics and Sedatives
Central Nervous System Depressants
Peripheral Nervous System Agents
Analgesics
Dexmedetomidine
Adrenergic Agonists

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

ClinicalTrials.gov processed this record on May 07, 2009