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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00800826
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : December 2, 2008
Information provided by:
National Taiwan University Hospital

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

Condition or disease Intervention/treatment Phase
Analgesia, Patient-Controlled Analgesia, Postoperative Drug: dexmedetomidine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Study Start Date : November 2006
Actual Study Completion Date : April 2008

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. Identifier: NCT00800826     History of Changes
Other Study ID Numbers: 950910
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: December 2, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action