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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary: 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.
Sponsor: Milton S. Hershey Medical Center

Current Primary Outcome: Length of time from extubation to discharge from postanesthesia recovery unit [ Time Frame: 24 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Postanesthesia Recovery Scale score [ Time Frame: 24 hours ]

Original Secondary Outcome: Same as current

Information By: Milton S. Hershey Medical Center

Dates:
Date Received: July 1, 2015
Date Started: February 2016
Date Completion: October 2017
Last Updated: January 11, 2017
Last Verified: January 2017