Modafinil to Prevent Postoperative Cognitive Decline

NCT03914118 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2023-09-29

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914118 on ClinicalTrials.gov