CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 750 enrolled
Drug / intervention
Gabapentindrug
Likely dose
Gabapentin adjusted for renal clearance, preoperatively and for first three postoperative daysAI-extracted
Key inclusion· 4
  • ✓Age ≥65 years
  • ✓Undergoing spine, hip, or knee replacement surgery
  • ✓Anticipated hospital stay of at least 48 hours
  • ✓English speaking
Key exclusion· 4
  • ✕Current or prior gabapentin use or known sensitivity to gabapentin
  • ✕History of narcotic tolerance
  • ✕Planned two-stage spinal procedures
  • ✕Unable to provide informed consent

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00221338
NCT00221338Phase 3Completed
CompareCT.gov

Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain in Surgical Patients

University of California, San Francisco·interventional·Posted Sep 22, 2005·Updated Sep 10, 2020

In Brief

A Phase 3 clinical trial evaluating Gabapentin for Postoperative Delirium and 3 related conditions. Completed, enrolled 750 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Delirium, Postoperative Pain, Opioid Use, Hospital Length of Stay
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 20.8 years ago

Interventions

Gabapentindrug

This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days