Modafinil to Prevent Postoperative Cognitive Decline

NCT ID: NCT03914118

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-01

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Preoperative modafinil + postoperative placebo

Group Type ACTIVE_COMPARATOR

Preoperative modafinil + postoperative placebo

Intervention Type DRUG

200 mg modafinil pre-operatively and placebo immediately post-operatively.

Preoperative modafinil + postoperative modafinil

Group Type ACTIVE_COMPARATOR

Preoperative modafinil + postoperative modafinil

Intervention Type DRUG

200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.

Preoperative placebo + postoperative placebo

Group Type PLACEBO_COMPARATOR

Preoperative placebo + postoperative placebo

Intervention Type DRUG

Placebo pre-operatively and placebo immediately post-operatively.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative modafinil + postoperative placebo

200 mg modafinil pre-operatively and placebo immediately post-operatively.

Intervention Type DRUG

Preoperative modafinil + postoperative modafinil

200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.

Intervention Type DRUG

Preoperative placebo + postoperative placebo

Placebo pre-operatively and placebo immediately post-operatively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists class I or II
* Elective surgery
* Surgery requiring general anesthesia

4.) Control Group will be-females \& males 65 and older not scheduled for any surgical procedures for at least a 3 month period.

Exclusion Criteria

* Neurosurgery
* Cardiac surgery
* Narcotic or illicit drug abuse
* Chronic opioid use
* Chronic use of anxiolytics
* History of pulmonary disease
* C02 retention
* Sleep apnea
* Obesity
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cooper Health System

OTHER

Sponsor Role lead

Responsible Party

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Ronak Desai, DO

Director, Division of Regional Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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08-086

Identifier Type: -

Identifier Source: org_study_id

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