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
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Computer generated randomization list, subject, clinical team and research team blinded to intervention
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Meets diagnostic criteria for obstructive sleep apnea
- •Willing and able to comply with study procedures
- •Willing and able to provide informed consent
- •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
- •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).
- •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).
- •Currently on prescription medication that is known to interact with the study drug. (ethinylestradiol and triazolam).
- •Have current dependence on cocaine, methamphetamine, alcohol or benzodiazepines (DSM-IV criteria).
- •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.
- •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).
- •Any condition, in the opinion of the principal investigators that would compromise patient safety.
- •A documented history of sensitivity to modafinil.
- •Current Modafinil use for daytime somnolence associated with obstructive sleep apnea.
Arms & Interventions
Placebo
Administered Placebo day of surgery immediately prior to general anesthesia and surgery
Intervention: Placebo (Drug)
Intervention
Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery
Intervention: Modafinil (Drug)
Outcomes
Primary Outcomes
Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit
Time Frame: 24 hours
Length of time of above compared between groups
Secondary Outcomes
- Postanesthesia Quality Recovery Scale Score(baseline and 6 hours after surgery)
Investigators
Zyad J. Carr, M.D.
Principal Investigator
Milton S. Hershey Medical Center