Trial Outcomes & Findings for Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients (NCT NCT02478580)

Results Overview

Participants will be followed for the duration of PACU stay, an expected average of 3 hours.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

67 participants

Primary outcome timeframe

Immediate postoperative period (up to 3 hours)

Results posted on

2018-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Nuvigil A single oral dose of Nuvigil 150mg in preoperative area NUVIGIL: Patient will receive Nuvigil before the surgery	Control Placebo in preoperative area Patient will receive placebo before the surgery
Overall Study STARTED	34	33
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nuvigil n=34 Participants A single oral dose of Nuvigil 150mg in preoperative area NUVIGIL: Patient will receive Nuvigil before the surgery	Control n=33 Participants Placebo in preoperative area	Total n=67 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 12.7 • n=99 Participants	54.7 years STANDARD_DEVIATION 10.8 • n=107 Participants	53.7 years STANDARD_DEVIATION 11.8 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	4 Participants n=107 Participants	9 Participants n=206 Participants
Sex: Female, Male Male	29 Participants n=99 Participants	29 Participants n=107 Participants	58 Participants n=206 Participants
Region of Enrollment United States	34 participants n=99 Participants	33 participants n=107 Participants	67 participants n=206 Participants

PRIMARY outcome

Timeframe: Immediate postoperative period (up to 3 hours)

Population: Patient with obstructive sleep apnea undergoing surgery

Participants will be followed for the duration of PACU stay, an expected average of 3 hours.

Outcome measures

Outcome measures
Measure	Nuvigil n=34 Participants A single oral dose of Nuvigil 150mg in preoperative area NUVIGIL: Patient will receive Nuvigil before the surgery	Control n=33 Participants Placebo in preoperative area
Postoperative Care Unit (PACU) Recovery Time	98.2 Minutes Standard Deviation 58.2	95 Minutes Standard Deviation 60.7

SECONDARY outcome

Timeframe: 2 hours after extubation

Aldrete score used for readiness of PACU discharge by assigning numeric values to the criteria including activity, respiration, circulation, consciousness, and color. Each criterion is rated from 0 to 2, with a maximum score of 10. Scores in the range of 9 to 10 are considered satisfactory for PACU discharge.

Outcome measures

Outcome measures
Measure	Nuvigil n=34 Participants A single oral dose of Nuvigil 150mg in preoperative area NUVIGIL: Patient will receive Nuvigil before the surgery	Control n=33 Participants Placebo in preoperative area
The Aldrete Score	9.4 units on a scale Standard Error 0.27	9.3 units on a scale Standard Error 0.26

Adverse Events

Nuvigil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr. Enas Kandil

University Of Texas Southwestern Medical Center

Phone: 214-590-8509

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place