Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-20 @ 12:46 PM
Study NCT ID:
NCT02494102
Status:
TERMINATED
Last Update Posted:
2019-06-20
First Post:
2015-07-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea
Sponsor:
Milton S. Hershey Medical Center
Organization:
Study Overview
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 Apnea
Status:
TERMINATED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ModOSA
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 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: