NCT Number: NCT00800826
The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA).
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Important dates
- Study start
- 2006
- Study completion
- 2008
- First posted
- Dec 2, 2008
- Registry last updated
- Dec 2, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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