Skip to main content
OpenTrials
Completed

NCT Number: NCT03914118

Modafinil to Prevent Postoperative Cognitive Decline

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative modafinil + postoperative placebo

Drug

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

Preoperative modafinil + postoperative modafinil

Drug

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

Preoperative placebo + postoperative placebo

Drug

Placebo pre-operatively and placebo immediately post-operatively.

Primary outcomes

  1. Rey Auditory Verbal Learning Test (RAVLT) scores

    Time frame: 3 months

    Rey Auditory Verbal Learning Test (RAVLT) scores will be used to assess memory and learning ability in the auditory-verbal domain. The RAVLT begins with a list of 15 words, which an examiner reads aloud at the rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then, the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. For each trial a maximum score of 15 can be obtained, which would reflect excellent memory. The obtained scores per individual trial will be compared between the 4 different arms.

    The RAVLT will be administered preoperatively, immediately postoperatively in the PACU (except the non-surgical control group), at 1 week and at 3 months postoperatively.

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2019
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.