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

Sponsors

Lead Sponsor: Milton S. Hershey Medical Center

Source Milton S. Hershey Medical Center
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.

Overall Status Terminated
Start Date February 2016
Completion Date April 1, 2018
Primary Completion Date April 1, 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit 24 hours
Secondary Outcome
Measure Time Frame
Postanesthesia Quality Recovery Scale Score baseline and 6 hours after surgery
Enrollment 105
Condition
Intervention

Intervention Type: Drug

Intervention Name: Modafinil

Description: Atypical Psychomotor stimulant

Arm Group Label: Intervention

Intervention Type: Drug

Intervention Name: Placebo

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

1. 18 years or older

2. Meets diagnostic criteria for obstructive sleep apnea

3. Willing and able to comply with study procedures

4. Willing and able to provide informed consent

5. If female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) for one month after surgery and discontinuation of study medication (modafinil may reduce the effectiveness of steroidal contraception for one month after discontinuation)

Exclusion Criteria:

1. Have a medical condition that, in the study physician's judgment, may interfere with safe participation (active cardiac conditions such as angina, recent myocardial infarction w/in 6 months, severe renal or liver disease, unstable diabetes, or elevated liver enzymes greater than twice normal).

2. Have a current neurological disorder (e.g. organic brain disease, dementia) or major psychiatric condition that would impair the collection of data (schizophrenia, bipolar illness).

3. Currently on prescription medication that is known to interact with the study drug. (ethinylestradiol and triazolam).

4. Have current dependence on cocaine, methamphetamine, alcohol or benzodiazepines (DSM-IV criteria).

5. Have a history of severe valvular heart disease, severe left ventricular hypertrophy, cardiac arrhythmias, angina, cardiac syncope, or pre-syncope or myocardial infarction <6 months.

6. Have a history of uncontrolled or poorly controlled essential hypertension, or a heart rate greater than 70% of the maximum heart rate expected for their age (Formula: 0.70(220 - age).

7. Any condition, in the opinion of the principal investigators that would compromise patient safety.

8. A documented history of sensitivity to modafinil.

9. Current Modafinil use for daytime somnolence associated with obstructive sleep apnea.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Zyad J Carr, M.D. Principal Investigator Milton S. Hershey Medical Center
Location
Facility: Penn State Hershey Medical Center
Location Countries

United States

Verification Date

June 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Milton S. Hershey Medical Center

Investigator Full Name: Zyad J. Carr, M.D.

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Administered Placebo day of surgery immediately prior to general anesthesia and surgery

Label: Intervention

Type: Active Comparator

Description: Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery

Acronym ModOSA
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: double blind randomized placebo controlled trial

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Masking Description: Computer generated randomization list, subject, clinical team and research team blinded to intervention

Source: ClinicalTrials.gov