Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain

NCT00221338 | Completed Phase 3 Results DMC

• 1 other identifier: H5636-26795-01
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Postoperative Delirium; Postoperative Pain; Opioid Use; Hospital Length of Stay

Keywords

gabapentin; pain; surgery; delirium; cognitive decline

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium by Study Group

  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.

  postoperative days 1, 2 and 3

Secondary Outcomes (5)

• Median Postoperative Opioid Doses Across Study Follow up Period

  Study follow up period: postoperative days 1, 2 and 3

• Hospital Length of Stay

  Typically within the first week after surgery

• Postoperative Pain Score - Postoperative Day 1

  Postoperative day 1

• Postoperative Pain Score - Postoperative Day 2

  Postoperative day 2

• Postoperative Pain Score - Postoperative Day 3

  Postoperative day 3

Study Arms (2)

Gabapentin

EXPERIMENTAL

Double blind, placebo controlled

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Double blind

Drug: Gabapentin

Interventions

Gabapentin DRUG

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

Also known as: gabapentin versus placebo

Gabapentin; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0648, United States

Location

Related Publications (2)

• Leung JM, Sands LP, Chen N, Ames C, Berven S, Bozic K, Burch S, Chou D, Covinsky K, Deviren V, Kinjo S, Kramer JH, Ries M, Tay B, Vail T, Weinstein P, Chang S, Meckler G, Newman S, Tsai T, Voss V, Youngblom E; Perioperative Medicine Research Group. Perioperative Gabapentin Does Not Reduce Postoperative Delirium in Older Surgical Patients: A Randomized Clinical Trial. Anesthesiology. 2017 Oct;127(4):633-644. doi: 10.1097/ALN.0000000000001804.

  PMID: 28727581 BACKGROUND

• Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. doi: 10.1212/01.wnl.0000233831.87781.a9. Epub 2006 Aug 16.

  PMID: 16914695 RESULT

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative; Pain; Delirium; Cognitive Dysfunction

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: University of California San Francisco

Christopher.Tang2@ucsf.edu

4154769489

Study Officials

• Jacqueline M Leung, MD, MPH

  University of California, San Francisco, CA, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2006
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 10, 2020
• Results First Posted: September 10, 2020

Record last verified: 2020-08

Locations

US (1)