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

NCT02478580 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2018-12-04

Study results available
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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.

Conditions

  • Obesity
  • Premature Recovery From Anesthesia

Interventions

DRUG

Nuvigil

Patients will receive Nuvigil before the surgery

DRUG

Placebo

Placebo will be given before surgery

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Enas Kandil, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-09-30
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478580 on ClinicalTrials.gov