Study Results
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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COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2008-01-01
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Preoperative modafinil + postoperative placebo
Preoperative modafinil + postoperative placebo
200 mg modafinil pre-operatively and placebo immediately post-operatively.
Preoperative modafinil + postoperative modafinil
Preoperative modafinil + postoperative modafinil
200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.
Preoperative placebo + postoperative placebo
Preoperative placebo + postoperative placebo
Placebo pre-operatively and placebo immediately post-operatively.
Control group
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.
Preoperative modafinil + postoperative modafinil
200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.
Preoperative placebo + postoperative placebo
Placebo pre-operatively and placebo immediately post-operatively.
Eligibility Criteria
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Inclusion Criteria
* 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
* Cardiac surgery
* Narcotic or illicit drug abuse
* Chronic opioid use
* Chronic use of anxiolytics
* History of pulmonary disease
* C02 retention
* Sleep apnea
* Obesity
65 Years
99 Years
ALL
Yes
Sponsors
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The Cooper Health System
OTHER
Responsible Party
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Ronak Desai, DO
Director, Division of Regional Anesthesia
Other Identifiers
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08-086
Identifier Type: -
Identifier Source: org_study_id
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