Modafinil to Prevent Postoperative Cognitive Decline

Cooper University Health Care

Status and phase: Completed; Phase 2

Conditions: Postoperative Cognitive Dysfunction

Treatments: Drug: Preoperative placebo + postoperative placebo; Drug: Preoperative modafinil + postoperative placebo; Drug: Preoperative modafinil + postoperative modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT03914118

08-086

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 65 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

137 participants in 4 patient groups, including a placebo group

Preoperative modafinil + postoperative placebo

Active Comparator group

Treatment:

Drug: Preoperative modafinil + postoperative placebo

Preoperative modafinil + postoperative modafinil

Active Comparator group

Treatment:

Drug: Preoperative modafinil + postoperative modafinil

Preoperative placebo + postoperative placebo

Placebo Comparator group

Treatment:

Drug: Preoperative placebo + postoperative placebo

Control group

No Intervention group