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

• ClinicalTrials.gov Identifier: NCT02478580
• Recruitment Status: Completed
• First Posted: June 23, 2015
• Results First Posted: March 23, 2016
• Last Update Posted: December 4, 2018
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Enas Kandil, University of Texas Southwestern Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Premature Recovery From Anesthesia	Drug: Nuvigil; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effects of Armodafinil (Nuvigil) on Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
• Actual Study Start Date: August 2011
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: January 2016

Arms and Interventions

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 Name: Armodafinil
Placebo Comparator: Placebo; A single oral placebo will be given in preoperative area	Drug: Placebo; Placebo will be given before surgery; Other Name: Oral placebo

Outcome Measures

Primary Outcome Measures :

1. Postoperative Care Unit (PACU) Recovery Time [ Time Frame: Immediate postoperative period (up to 3 hours) ]
   Participants will be followed for the duration of PACU stay, an expected average of 3 hours.

Secondary Outcome Measures :

1. The Aldrete Score [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390-9068

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Enas Kandil, MD; UT Southwestern Medical Center

More Information

• Responsible Party: Enas Kandil, Medical Doctor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02478580
• Other Study ID Numbers: 10-041
• First Posted: June 23, 2015
• Results First Posted: March 23, 2016
• Last Update Posted: December 4, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Enas Kandil, University of Texas Southwestern Medical Center:

Obstructive Sleep Apnea; Anesthesia Recovery Period

Additional relevant MeSH terms:

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Modafinil; Central Nervous System Stimulants; Physiological Effects of Drugs; Wakefulness-Promoting Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action