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

NCT02478580 | Completed Phase 3 Results

• 1 other identifier: 10-041
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obstructive Sleep Apnea; Anesthesia Recovery Period

Outcome Measures

Primary Outcomes (1)

• Postoperative Care Unit (PACU) Recovery Time

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

  Immediate postoperative period (up to 3 hours)

Secondary Outcomes (1)

• The Aldrete Score

  2 hours after extubation

Study Arms (2)

Nuvigil

EXPERIMENTAL

A single oral dose of Nuvigil at 150mg dose in preoperative area

Drug: Nuvigil

Placebo

PLACEBO COMPARATOR

A single oral placebo will be given in preoperative area

Drug: Placebo

Interventions

Nuvigil DRUG

Patients will receive Nuvigil before the surgery

Also known as: Armodafinil

Nuvigil

Placebo DRUG

Placebo will be given before surgery

Also known as: Oral placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presented for surgery under general anesthesia
• Documented OSA
• Patients with BMI above 35

You may not qualify if:

• Coronary Artery Disease or Myocardial infarcts
• Mitral valve prolapse
• Cyclosporine, contraceptive drugs
• Known allergic reaction to Modafinil or any of its products

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9068, United States

Location

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Enas Kandil
• Organization: University Of Texas Southwestern Medical Center

Enas.Kandil@UTSouthwestern.edu

214-590-8509

Study Officials

• Enas Kandil, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 23, 2015
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2016
• Last Updated: December 4, 2018
• Results First Posted: March 23, 2016

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)