Status:
COMPLETED
Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain
Lead Sponsor:
University of California, San Francisco
Conditions:
Postoperative Delirium
Postoperative Pain
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
This will be a double blind, placebo-controlled study of patients ≥65 years of age undergoing surgery of the spine, hips and knees replacement at the University of California, San Francisco (UCSF) Med...
Detailed Description
Postoperative delirium is a common condition, occurring in 10-70% of surgical patients after major surgery. To date, few studies have examined events in the postoperative period as contributing factor...
Eligibility Criteria
Inclusion
- Male or female ≥65 years of age undergoing surgery involving the spine, hip or knee replacement.
- English speaking.
- Anticipated to stay in the hospital for at least 48 hours.
Exclusion
- Patients who take gabapentin preoperatively, or have known sensitivity to the drug, or those unable to be randomized to receive gabapentin.
- Subjects who are unable to provide informed consent.
- Patients with a history of narcotic tolerance.
- Patients with planned two stage spinal procedures (anterior-posterior spinal fusion to be done on two separate days).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00221338
Start Date
January 1 2006
End Date
July 1 2014
Last Update
September 10 2020
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143-0648