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

Penn State Health

Status and phase: Terminated; Phase 4

Conditions: Delayed Emergence From Anesthesia; Obstructive Sleep Apnea

Treatments: Drug: Placebo; Drug: Modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT02494102

CAPITALSTUDY00002957

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Intervention

Active Comparator group

Description:

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

Treatment:

Drug: Modafinil