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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 is a Phase 3 study that has completed, run by University of California, San Francisco. The registered enrollment target is 750 participants.
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.
Interventions
- DRUG Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2006-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00221338
The ClinicalTrials.gov registry entry for NCT00221338 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 750 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gabapentin is the first listed.
NCT00221338 reports 0 study locations.
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.
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