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

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.

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.