Modafinil to Prevent Postoperative Cognitive Decline

Postoperative Cognitive Dysfunction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914118
• Other study ID #: 08-086
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2008
• Est. completion date: January 31, 2013

Study information

• Verified date: September 2023
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 31, 2013
• Est. primary completion date: January 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rey Auditory Verbal Learning Test (RAVLT) scores	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.	3 months