Trial Outcomes & Findings for Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea (NCT NCT02494102)

NCT ID: NCT02494102

Last Updated: 2019-06-20

Results Overview

Length of time of above compared between groups

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 105 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2019-06-20

Participant Flow

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.

Participant milestones

Measure	Placebo Administered Placebo day of surgery immediately prior to general anesthesia and surgery Placebo	Modafinil Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery Modafinil: Atypical Psychomotor stimulant
Overall Study STARTED	42	47
Overall Study COMPLETED	42	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo n=42 Participants Administered Placebo day of surgery immediately prior to general anesthesia and surgery Placebo	Modafinil n=47 Participants Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery Modafinil: Atypical Psychomotor stimulant	Total n=89 Participants Total of all reporting groups
Age, Continuous	56.0 years STANDARD_DEVIATION 13 • n=42 Participants	54 years STANDARD_DEVIATION 13 • n=47 Participants	55 years STANDARD_DEVIATION 13 • n=89 Participants
Sex: Female, Male Female	19 Participants n=42 Participants	24 Participants n=47 Participants	43 Participants n=89 Participants
Sex: Female, Male Male	23 Participants n=42 Participants	23 Participants n=47 Participants	46 Participants n=89 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Surgery Type abdominal surgey	27 Participants n=42 Participants	30 Participants n=47 Participants	57 Participants n=89 Participants
Surgery Type orthopedic surgery	2 Participants n=42 Participants	5 Participants n=47 Participants	7 Participants n=89 Participants
Surgery Type gynecology	4 Participants n=42 Participants	7 Participants n=47 Participants	11 Participants n=89 Participants
Surgery Type otolaryngology	8 Participants n=42 Participants	5 Participants n=47 Participants	13 Participants n=89 Participants
Surgery Type opthalmology	1 Participants n=42 Participants	0 Participants n=47 Participants	1 Participants n=89 Participants
Body Mass Index (BMI)	38.2 kg/m^2 STANDARD_DEVIATION 11.1 • n=42 Participants	44.9 kg/m^2 STANDARD_DEVIATION 11.6 • n=47 Participants	41.9 kg/m^2 STANDARD_DEVIATION 11.3 • n=89 Participants
Hypertension	26 participants n=42 Participants	33 participants n=47 Participants	59 participants n=89 Participants
History of Delayed Emergence	0 Participants n=42 Participants	0 Participants n=47 Participants	0 Participants n=89 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: 16 participants violated the study protocol

Length of time of above compared between groups

Outcome measures

Measure	Placebo n=42 Participants Administered Placebo day of surgery immediately prior to general anesthesia and surgery Placebo	Modafinil n=47 Participants Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery Modafinil: Atypical Psychomotor stimulant
Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit	53.5 minutes Interval 41.0 to 80.0	61.0 minutes Interval 46.0 to 91.0

SECONDARY outcome

Timeframe: baseline and 6 hours after surgery

Population: 16 patients violated study protocol and were excluded

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.

Outcome measures

Measure	Placebo n=42 Participants Administered Placebo day of surgery immediately prior to general anesthesia and surgery Placebo	Modafinil n=47 Participants Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery Modafinil: Atypical Psychomotor stimulant
Postanesthesia Quality Recovery Scale Score	-5.67 units on a scale Standard Deviation 4.74	-8.91 units on a scale Standard Deviation 7.98

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zyad J. Carr, M.D., FASA

Penn State Health Milton S. Hershey Medical Center

Phone: 717-531-8521

Email: zcarr@pennstatehealth.psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place