- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00800826
The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
December 1, 2008 updated by: National Taiwan University Hospital
This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA).
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
150
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
December 1, 2008
First Submitted That Met QC Criteria
December 1, 2008
First Posted (Estimate)
December 2, 2008
Study Record Updates
Last Update Posted (Estimate)
December 2, 2008
Last Update Submitted That Met QC Criteria
December 1, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Perceptual Disorders
- Agnosia
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 950910
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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