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
About this trial
This is an interventional health services research trial for Analgesia, Patient-Controlled
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00800826
First Posted
December 1, 2008
Last Updated
December 1, 2008
Sponsor
National Taiwan University Hospital
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
Learn more about this trial
The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
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