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

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

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 Overview

• Status: Completed
• Conditions: Obesity; Premature Recovery From Anesthesia
• Intervention / Treatment: Drug: Nuvigil; Drug: Placebo

Detailed Description

Modafinil has been shown to improve recovery after general anesthesia in a small pilot study which involved 30 patients. In these study, patients were given one dose of Modafinil 200mg po versus placebo after surgery when patient tolerating po with a sip of water and were discharged home. They were asked to assess their fatigue, alertness and energy level during the following 24 hrs. Modafinil was found to significantly reduce fatigue and improves feelings of alertness and energy in postoperative patients. It was concluded that patients recovering from general anesthesia can significantly benefit from Modafinil.

A more recent study looked at the perioperative use of Modafinil in 67 patients presenting for lithotripsy requiring sedation. Goal was to asses improvement in recovery compared to placebo. Patients were randomized to 4 groups 1 and 2 received midazolam/ fentanyl sedation plus Modafinil 200mg po given 1 hr before sedation versus placebo, the other two received remifentanil / propofol infusion plus Modafinil 20 mg po versus placebo. Groups were compared using the digital symbol substitution test (DSST), trail making test (TMT), observer scale of sedation and analgesia (OAA/S) and Aldrete score and they found no statistical significant difference between groups. However they measured the Verbal rating scale (VRS) scores for secondary outcome variables e.g. energy, tiredness and dizziness were also recorded before and after treatment. They concluded that Modafinil reduces patient-reported tiredness after sedation/analgesia however does not improve recovery in terms of objective measures of patient psychomotor skills.

Nuvigil is longer acting product which is similar in action to Modafinil and has not been previously studied for postoperative recovery. We intend to study the effects of Nuvigil on postoperative recovery time and wakefulness in obstructive sleep apnea patients and obese patients.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9068
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nuvigil; A single oral dose of Nuvigil at 150mg dose in preoperative area	Drug: Nuvigil; Patients will receive Nuvigil before the surgery; Other Names: Armodafinil
Placebo Comparator: Placebo; A single oral placebo will be given in preoperative area	Drug: Placebo; Placebo will be given before surgery; Other Names: Oral placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Aldrete Score	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.	2 hours after extubation

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Enas Kandil, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Anesthesia Recovery Period
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: 10-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No