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

NCT00800826 | Completed Phase 4

• 1 other identifier: 950910
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Analgesia, Patient-Controlled; Analgesia, Postoperative

Interventions

dexmedetomidine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: November 1, 2006
• Study Completion: April 1, 2008
• Last Updated: December 2, 2008

Record last verified: 2008-12