Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea
Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstructive Sleep Apnea; Delayed Emergence From Anesthesia
Intervention: Modafinil (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Milton S. Hershey Medical Center Official(s) and/or principal investigator(s): Zyad J Carr, M.D., Principal Investigator, Affiliation: Milton S. Hershey Medical Center
Overall contact: Zyad J Carr, M.D., Phone: 717-531-0003, Ext: 281082, Email: zcarr@hmc.psu.edu
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Length of time from extubation to discharge from postanesthesia recovery unit
Secondary outcome: Postanesthesia Recovery Scale score
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Zyad J Carr, M.D., Phone: 717-531-0003, Ext: 281082, Email: zcarr@hmc.psu.edu Additional Information
Related publications: Minzenberg MJ, Carter CS. Modafinil: a review of neurochemical actions and effects on cognition. Neuropsychopharmacology. 2008 Jun;33(7):1477-502. Epub 2007 Aug 22. Review. Moldofsky H, Broughton RJ, Hill JD. A randomized trial of the long-term, continued efficacy and safety of modafinil in narcolepsy. Sleep Med. 2000 Apr 1;1(2):109-116. Jasinski DR, Kovacević-Ristanović R. Evaluation of the abuse liability of modafinil and other drugs for excessive daytime sleepiness associated with narcolepsy. Clin Neuropharmacol. 2000 May-Jun;23(3):149-56. Review. Jasinski DR. An evaluation of the abuse potential of modafinil using methylphenidate as a reference. J Psychopharmacol. 2000 Mar;14(1):53-60. Wisor JP, Nishino S, Sora I, Uhl GH, Mignot E, Edgar DM. Dopaminergic role in stimulant-induced wakefulness. J Neurosci. 2001 Mar 1;21(5):1787-94. Arnulf I, Homeyer P, Garma L, Whitelaw WA, Derenne JP. Modafinil in obstructive sleep apnea-hypopnea syndrome: a pilot study in 6 patients. Respiration. 1997;64(2):159-61. Pack AI, Black JE, Schwartz JR, Matheson JK. Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1675-81. Larijani GE, Goldberg ME, Hojat M, Khaleghi B, Dunn JB, Marr AT. Modafinil improves recovery after general anesthesia. Anesth Analg. 2004 Apr;98(4):976-81, table of contents. Galvin E, Boesjes H, Hol J, Ubben JF, Klein J, Verbrugge SJ. Modafinil reduces patient-reported tiredness after sedation/analgesia but does not improve patient psychomotor skills. Acta Anaesthesiol Scand. 2010 Feb;54(2):154-61. doi: 10.1111/j.1399-6576.2009.02093.x. Epub 2009 Aug 31.
Starting date: August 2015
Last updated: July 9, 2015
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