Modafinil to Prevent Postoperative Cognitive Decline
NCT03914118 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137
Last updated 2023-09-29
Summary
Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.
Conditions
- Postoperative Cognitive Dysfunction
Interventions
- DRUG
-
Preoperative modafinil + postoperative placebo
200 mg modafinil pre-operatively and placebo immediately post-operatively.
- DRUG
-
Preoperative modafinil + postoperative modafinil
200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.
- DRUG
-
Preoperative placebo + postoperative placebo
Placebo pre-operatively and placebo immediately post-operatively.
Sponsors & Collaborators
-
The Cooper Health System
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-01-01
- Primary Completion
- 2013-01-31
- Completion
- 2013-01-31
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