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

NCT02494102 | Terminated Phase 4 Results DMC

• 1 other identifier: CAPITALSTUDY00002957
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea; Delayed Emergence From Anesthesia

Keywords

Obstructive Sleep Apnea; General Anesthesia; Modafinil

Outcome Measures

Primary Outcomes (1)

• Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit

  Length of time of above compared between groups

  24 hours

Secondary Outcomes (1)

• Postanesthesia Quality Recovery Scale Score

  baseline and 6 hours after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Intervention

ACTIVE COMPARATOR

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

Drug: Modafinil

Interventions

Modafinil DRUG

Atypical Psychomotor stimulant

Also known as: Armodafinil, Provigil

Intervention

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Meets diagnostic criteria for obstructive sleep apnea
• Willing and able to comply with study procedures
• Willing and able to provide informed consent
• 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)

You may not qualify if:

• 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).
• 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).
• Currently on prescription medication that is known to interact with the study drug. (ethinylestradiol and triazolam).
• Have current dependence on cocaine, methamphetamine, alcohol or benzodiazepines (DSM-IV criteria).
• 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.
• 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).
• Any condition, in the opinion of the principal investigators that would compromise patient safety.
• A documented history of sensitivity to modafinil.
• Current Modafinil use for daytime somnolence associated with obstructive sleep apnea.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (9)

• 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.

  PMID: 17712350 BACKGROUND

• 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.

  PMID: 10767651 BACKGROUND

• 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.

  PMID: 10895398 BACKGROUND

• 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.

  PMID: 10757254 BACKGROUND

• 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.

  PMID: 11222668 BACKGROUND

• 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.

  PMID: 9097352 BACKGROUND

• 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.

  PMID: 11719309 BACKGROUND

• 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.

  PMID: 15041583 BACKGROUND

• 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.

  PMID: 19719817 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Delayed Emergence from Anesthesia

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Trial terminated for statistical futility on scheduled interim analysis

Results Point of Contact

• Title: Zyad J. Carr, M.D., FASA
• Organization: Penn State Health Milton S. Hershey Medical Center

zcarr@pennstatehealth.psu.edu

717-531-8521

Study Officials

• Zyad J Carr, M.D.

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Computer generated randomization list, subject, clinical team and research team blinded to intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double blind randomized placebo controlled trial

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 10, 2015
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-06

Locations

US (1)