Modafinil to Prevent Postoperative Cognitive Decline

Phase 2

Completed

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Drug: Preoperative modafinil + postoperative modafinil; Drug: Preoperative modafinil + postoperative placebo; Drug: Preoperative placebo + postoperative placebo

• Registration Number: NCT03914118
• Lead Sponsor: The Cooper Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2013-01-31
• Study Completion: 2013-01-31
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative modafinil + postoperative modafinil	Preoperative modafinil + postoperative modafinil	-
Preoperative modafinil + postoperative placebo	Preoperative modafinil + postoperative placebo	-
Preoperative placebo + postoperative placebo	Preoperative placebo + postoperative placebo	-

Primary Outcome Measures

Name	Time	Method
Rey Auditory Verbal Learning Test (RAVLT) scores	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.