CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 67 enrolled
Drug / intervention
Nuvigil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02478580
NCT02478580Phase 3Completed

The Effects of Armodafinil (Nuvigil) on Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients

University of Texas Southwestern Medical Center·interventional·Posted Jun 23, 2015·Updated Dec 4, 2018

In Brief

A Phase 3 clinical trial evaluating Nuvigil and Placebo for Obesity and Premature Recovery From Anesthesia. Completed, enrolled 67 participants across 1 site.

Detailed Summary

Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative morbidity and mortality. This group of patients is at risk of perioperative desaturations which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA patients might also need to spend the night in intensive care for more frequent monitoring for any desaturations episodes especially if the patient will be requiring multiple intravenous narcotic boluses for pain control. Several studies have looked into the most appropriate way to manage these patients and some recommendations have been made to avoid outpatient surgery with close monitoring for first 24 hours after surgery specifically if patient will require intravenous postoperative narcotics. Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer) or modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown. Nuvigil is longer acting product which is similar in action to Modafinil however is much cheaper. Nuvigil has not been previously studied for postoperative recovery. The investigators intend to study the effects of Nuvigil on postoperative recovery time and wakefulness in obstructive sleep apnea and obese patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2015
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2013
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.0 years ago

Interventions

Nuvigildrug

Patients will receive Nuvigil before the surgery

Placebodrug

Placebo will be given before surgery