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NCT00221338 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain
A Phase 3 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 3
- Development phase
- 750
- Enrollment target
NCT00221338: Completed Phase 3 study, sponsored by University of California, San Francisco.
NCT00221338 is a Phase 3 study that has completed, run by University of California, San Francisco. The registered enrollment target is 750 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00221338, a Phase 3 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 750 participants
- Enrollment target
Study 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) Medical Center. Intraoperative anesthetic and postoperative pain management will be standardized. Patients will be randomized to receive either placebo or gabapentin preoperatively, and continued postoperatively until discharge. Intraoperative anesthetic and other postoperative pain management strategies will be standardized. Postoperative delirium will be measured using structured interviews. Cognitive function will be measured using a battery of neurocognitive tests pre- and post-operatively. Using an intention to treat strategy, we, the researchers at UCSF, will compare the incidence of postoperative delirium and cognitive dysfunction, the amount of postoperative pain, and narcotic requirements between the two groups. The primary outcome will be postoperative delirium. Secondary outcomes will be postoperative pain and opioids use, and length of hospital stay, and cognitive dysfunction.
Primary Outcome
Number of subjects who developed postoperative delirium, as measured by the Confusion Assessment Method, a validated tool for assessing delirium based on DSM-III-R, on any of the first three postoperative days.
Interventions
- DRUG Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2006-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT00221338 record still lists
NCT00221338 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Gabapentin is the first listed.
NCT00221338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00221338 about?
NCT00221338 is a clinical study titled "Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain". 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) Medical Center. Intraoperative anesthetic and postoperative pain management will be standardized. Patie...
What is the current status of trial NCT00221338?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 2006-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00221338?
The interventions under investigation include: Gabapentin (DRUG).
Who is sponsoring clinical trial NCT00221338?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00221338's enrollment target sits among peer trials
750 464th of 2000 higher than 1,529 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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