Modafinil to Prevent Postoperative Cognitive Decline

NCT03914118 | Completed Phase 2

• 1 other identifier: 08-086
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Preoperative modafinil + postoperative placebo

ACTIVE COMPARATOR

Drug: Preoperative modafinil + postoperative placebo

Preoperative modafinil + postoperative modafinil

ACTIVE COMPARATOR

Drug: Preoperative modafinil + postoperative modafinil

Preoperative placebo + postoperative placebo

PLACEBO COMPARATOR

Drug: Preoperative placebo + postoperative placebo

Control group

NO INTERVENTION

Interventions

Preoperative modafinil + postoperative placebo DRUG

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

Preoperative modafinil + postoperative placebo

Preoperative modafinil + postoperative modafinil DRUG

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

Preoperative modafinil + postoperative modafinil

Preoperative placebo + postoperative placebo DRUG

Placebo pre-operatively and placebo immediately post-operatively.

Preoperative placebo + postoperative placebo

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists class I or II
• Elective surgery
• Surgery requiring general anesthesia
• ) Control Group will be-females \& males 65 and older not scheduled for any surgical procedures for at least a 3 month period.

You may not qualify if:

• Neurosurgery
• Cardiac surgery
• Narcotic or illicit drug abuse
• Chronic opioid use
• Chronic use of anxiolytics
• History of pulmonary disease
• C02 retention
• Sleep apnea
• Obesity

Sponsors & Collaborators

• The Cooper Health System: lead

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Regional Anesthesia

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: January 1, 2008
• Primary Completion: January 31, 2013
• Study Completion: January 31, 2013
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share