This trial is active, not recruiting.

Conditions obesity, obstructive sleep apnea
Treatment nuvigil
Phase phase 3
Sponsor University of Texas Southwestern Medical Center
Start date August 2011
End date September 2013
Trial size 96 participants
Trial identifier NCT02478580, 10-041


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
(Active Comparator)
A single oral dose of Nuvigil 150mg in preoperative area
nuvigil Armodafinil
Patient will receive Nuvigil before the surgery
(Placebo Comparator)
Placebo in preoperative area

Primary Outcomes

Postoperative Care Unit (PACU) Recovery Time
time frame: Immediate postoperative period (up to 3 hours)

Secondary Outcomes

The Ramsey Sedation Score
time frame: 30 min, 1 hour and 2 hours after extubation

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Patient presented for surgery under general anesthesia with 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 - ASA 4

Additional Information

Official title The Effects of Armodafinil (Nuvigil) on Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
Principal investigator Enas Kandil
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.