NCT02494102

Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea

A Randomized, Double Blind, Placebo Controlled Evaluation of Modafinil vs Placebo for the Treatment of General Anesthesia Related Delayed Emergence in Patients With the Diagnosis of Obstructive Sleep Apnea

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether modafinil use in patients with obstructive sleep apnea will improve postoperative delayed emergence after general anesthesia.

Detailed description

This is a randomized, double blind placebo controlled evaluation of modafinil versus placebo for the treatment of general anesthesia related delayed emergence in patients with the diagnosis of obstructive sleep apnea. 124 patients will be recruited and randomized on the day of surgery to receive 200mg modafinil or placebo. After randomization, patients will proceed to the operative suite for surgical procedure under general anesthesia. The primary outcome measured will be post-anesthesia care unit length of stay. Secondary outcomes will include performance on a post-anesthesia recovery scale.

Conditions

• Obstructive Sleep Apnea
• Delayed Emergence From Anesthesia

Interventions

Type	Name	Description
DRUG	Modafinil	Atypical Psychomotor stimulant
DRUG	Placebo

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2015-07-10
• Last updated: 2019-06-20
• Results posted: 2019-06-20

Locations

1 site across 1 country: United States