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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Administered Placebo day of surgery immediately prior to general anesthesia and surgery |
|
| Intervention | Active Comparator | Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | Atypical Psychomotor stimulant |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit | Length of time of above compared between groups | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postanesthesia Quality Recovery Scale Score | Postanesthesia quality recovery scale (PQRS). Component and aggregate scoring on the scale. Measures physiology, nociceptive, emotional activities of daily living cognitive and overall patient perspective. The scale is dimensionless and the aggregate of all individually tested dimensions is scaled from 17-65. A higher value implies improved postanesthesia recovery. Mean difference was assessed in each patient and aggregated thus patients with no difference between pre- and post-operative scores were zeroed (received a zero score if the difference was zero). A negative value was associated with worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zyad J Carr, M.D. | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17712350 | Background | 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. | |
| 10767651 | 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. |
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16 patients violated the study protocol and were excluded from the study. Exclusions included Day of Surgery refusal of study medication, surgical case cancellation, and surgeon refusal to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Administered Placebo day of surgery immediately prior to general anesthesia and surgery Placebo |
| FG001 | Modafinil | Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery Modafinil: Atypical Psychomotor stimulant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
16 patients violated the study protocol and were excluded from the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Administered Placebo day of surgery immediately prior to general anesthesia and surgery Placebo |
| BG001 | Modafinil | Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery Modafinil: Atypical Psychomotor stimulant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit | Length of time of above compared between groups | 16 participants violated the study protocol | Posted | Mean | Inter-Quartile Range | minutes | 24 hours |
|
Perioperative time period (within 24 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Administered Placebo day of surgery immediately prior to general anesthesia and surgery Placebo |
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Trial terminated for statistical futility on scheduled interim analysis
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zyad J. Carr, M.D., FASA | Penn State Health Milton S. Hershey Medical Center | 717-531-8521 | zcarr@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2017 | Jun 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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double blind randomized placebo controlled trial
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Computer generated randomization list, subject, clinical team and research team blinded to intervention
| Placebo | Drug |
|
| baseline and 6 hours after surgery |
| 10895398 | 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. |
| 10757254 | 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. |
| 11222668 | 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. |
| 9097352 | 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. |
| 11719309 | 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. |
| 15041583 | 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. |
| 19719817 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Surgery Type | Proportions by surgical procedure: abdominal surgery, orthopedic surgery, gynecology, otolaryngology, ophthalmology. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body Mass Index = weight in kilograms divided by the square of height in meters. This variable was measured preoperatively prior to intervention. | Mean | Standard Deviation | kg/m^2 |
|
| Hypertension | number of participants with the diagnosis of hypertension | Number | participants |
|
| History of Delayed Emergence | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Postanesthesia Quality Recovery Scale Score | Postanesthesia quality recovery scale (PQRS). Component and aggregate scoring on the scale. Measures physiology, nociceptive, emotional activities of daily living cognitive and overall patient perspective. The scale is dimensionless and the aggregate of all individually tested dimensions is scaled from 17-65. A higher value implies improved postanesthesia recovery. Mean difference was assessed in each patient and aggregated thus patients with no difference between pre- and post-operative scores were zeroed (received a zero score if the difference was zero). A negative value was associated with worse outcome. | 16 patients violated study protocol and were excluded | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 hours after surgery |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Intervention | Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery Modafinil: Atypical Psychomotor stimulant | 0 | 47 | 0 | 47 | 0 | 47 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| gynecology |
|
| otolaryngology |
|
| opthalmology |
|