Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; Delayed Emergence From Anesthesia
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Delayed Emergence from Anesthesia
Intervention: Modafinil; Placebo
Intervention description: Atypical Psychomotor stimulant
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind randomized placebo controlled trial
Masking: Double (Participant, Investigator)
Masking description: Computer generated randomization list, subject, clinical team and research team blinded to intervention
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea; General Anesthesia; Modafinil

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.
    

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.