Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea
NCT ID: NCT02494102
Last Updated: 2019-06-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
105 participants
INTERVENTIONAL
2016-02-29
2018-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Administered Placebo day of surgery immediately prior to general anesthesia and surgery
Placebo
Intervention
Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery
Modafinil
Atypical Psychomotor stimulant
Interventions
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Modafinil
Atypical Psychomotor stimulant
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Zyad J. Carr, M.D.
Principal Investigator
Principal Investigators
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Zyad J Carr, M.D.
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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Minzenberg MJ, Carter CS. Modafinil: a review of neurochemical actions and effects on cognition. Neuropsychopharmacology. 2008 Jun;33(7):1477-502. doi: 10.1038/sj.npp.1301534. Epub 2007 Aug 22.
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. doi: 10.1016/s1389-9457(99)00014-3.
Jasinski DR, Kovacevic-Ristanovic 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. doi: 10.1097/00002826-200005000-00004.
Jasinski DR. An evaluation of the abuse potential of modafinil using methylphenidate as a reference. J Psychopharmacol. 2000 Mar;14(1):53-60. doi: 10.1177/026988110001400107.
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. doi: 10.1523/JNEUROSCI.21-05-01787.2001.
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. doi: 10.1159/000196661.
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. doi: 10.1164/ajrccm.164.9.2103032.
Larijani GE, Goldberg ME, Hojat M, Khaleghi B, Dunn JB, Marr AT. Modafinil improves recovery after general anesthesia. Anesth Analg. 2004 Apr;98(4):976-981. doi: 10.1213/01.ANE.0000108485.29288.B4.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CAPITALSTUDY00002957
Identifier Type: -
Identifier Source: org_study_id
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