Trial Outcomes & Findings for Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain (NCT NCT00221338)

Last Updated: 2020-09-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

750 participants

Primary outcome timeframe

postoperative days 1, 2 and 3

Results posted on

2020-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Gabapentin Double blind, placebo controlled Gabapentin: 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	Placebo Double blind Gabapentin: 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
Overall Study STARTED	374	376
Overall Study COMPLETED	350	347
Overall Study NOT COMPLETED	24	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: postoperative days 1, 2 and 3

Outcome measures

Outcome measures
Measure	Gabapentin n=350 Participants Double blind, placebo controlled Gabapentin: 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	Placebo n=347 Participants Double blind Gabapentin: 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
Incidence of Postoperative Delirium by Study Group	84 Participants	72 Participants

SECONDARY outcome

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

Postoperative intravenous opioid doses converted to morphine equivalents. Median derived from total opioid doses on first, second and third postoperative days.

Outcome measures

Outcome measures
Measure	Gabapentin n=350 Participants Double blind, placebo controlled Gabapentin: 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	Placebo n=347 Participants Double blind Gabapentin: 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
Median Postoperative Opioid Doses Across Study Follow up Period	6.7 morphine equivalents, mg Interval 1.3 to 20.0	6.7 morphine equivalents, mg Interval 2.7 to 24.8

SECONDARY outcome

Timeframe: Typically within the first week after surgery

Outcome measures

Outcome measures
Measure	Gabapentin n=350 Participants Double blind, placebo controlled Gabapentin: 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	Placebo n=347 Participants Double blind Gabapentin: 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
Hospital Length of Stay	4.4 days Standard Deviation 3.4	4.1 days Standard Deviation 2.3

SECONDARY outcome

Timeframe: Postoperative day 1

Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).

Outcome measures

Outcome measures
Measure	Gabapentin n=350 Participants Double blind, placebo controlled Gabapentin: 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	Placebo n=347 Participants Double blind Gabapentin: 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
Postoperative Pain Score - Postoperative Day 1	4 score on a scale Standard Deviation 3	4 score on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: Postoperative day 2

Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).

Outcome measures

Outcome measures
Measure	Gabapentin n=335 Participants Double blind, placebo controlled Gabapentin: 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	Placebo n=343 Participants Double blind Gabapentin: 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
Postoperative Pain Score - Postoperative Day 2	3 score on a scale Standard Deviation 3	4 score on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: Postoperative day 3

Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).

Outcome measures

Outcome measures
Measure	Gabapentin n=299 Participants Double blind, placebo controlled Gabapentin: 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	Placebo n=291 Participants Double blind Gabapentin: 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
Postoperative Pain Score - Postoperative Day 3	3 score on a scale Standard Deviation 3	3 score on a scale Standard Deviation 3

Adverse Events

Gabapentin

Serious events: 31 serious events

Other events: 42 other events

Deaths: 0 deaths

Placebo

Serious events: 44 serious events

Other events: 67 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Gabapentin n=350 participants at risk Double blind, placebo controlled Gabapentin: 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	Placebo n=347 participants at risk Double blind Gabapentin: 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
Respiratory, thoracic and mediastinal disorders Oxygen Desaturation	10.6% 37/350 • Number of events 37 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	16.1% 56/347 • Number of events 56 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).
Nervous system disorders Sedation	0.86% 3/350 • Number of events 3 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	1.7% 6/347 • Number of events 6 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).
General disorders Syncope	0.00% 0/350 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	1.4% 5/347 • Number of events 5 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).
General disorders Dysphagia	0.29% 1/350 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	0.00% 0/347 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).
Gastrointestinal disorders Ileus	0.29% 1/350 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	0.29% 1/347 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).
General disorders Orthostatic Hypotension	0.29% 1/350 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	0.29% 1/347 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).
General disorders Dizziness	0.29% 1/350 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	0.58% 2/347 • Number of events 2 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).
General disorders Nausea	0.29% 1/350 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	0.29% 1/347 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).
Nervous system disorders Hallucinations	0.29% 1/350 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).	0.29% 1/347 • Number of events 1 • Adverse event data were collected over the time period of 1 year. In-hospital course was examined daily until discharge for occurrence of postoperative outcomes. All serious adverse events (both anticipated and unanticipated) were reported to the University of California San Francisco Committee on Human Research, and National Institutes of Health (San Francisco, California).

Additional Information

Clinical Research Coordinator

University of California San Francisco

Phone: 4154769489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Gabapentin n=350 Participants Double blind, placebo controlled Gabapentin: 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	Placebo n=347 Participants Double blind Gabapentin: 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	Total n=697 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	350 Participants n=5 Participants	347 Participants n=7 Participants	697 Participants n=5 Participants
Age, Continuous	73 years STANDARD_DEVIATION 6 • n=5 Participants	72 years STANDARD_DEVIATION 6 • n=7 Participants	73 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	193 Participants n=5 Participants	158 Participants n=7 Participants	351 Participants n=5 Participants
Sex: Female, Male Male	157 Participants n=5 Participants	189 Participants n=7 Participants	346 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	323 Participants n=5 Participants	315 Participants n=7 Participants	638 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment United States	350 participants n=5 Participants	347 participants n=7 Participants	697 participants n=5 Participants
Preoperative Cognitive Status as measured by Telephone Interview for Cognitive Status	34.5 units on a scale STANDARD_DEVIATION 3.5 • n=5 Participants	34.5 units on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	34.5 units on a scale STANDARD_DEVIATION 3.3 • n=5 Participants