Trial | NCT03914118  Report issue

Title

Modafinil to Prevent Postoperative Cognitive Decline
An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    137
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.
Study Started
Jan 01
2008
Primary Completion
Jan 31
2013
Study Completion
Jan 31
2013
Last Update
Sep 29
2023

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.

Preoperative modafinil + postoperative placebo Active Comparator

Preoperative modafinil + postoperative modafinil Active Comparator

Preoperative placebo + postoperative placebo Placebo Comparator

Control group No Intervention

Criteria 

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
No Results Posted