Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
Condition: Obesity; Premature Recovery From Anesthesia
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Nuvigil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive Nuvigil before the surgery; Placebo will be given before surgery
Other intervention name(s): Armodafinil; Oral placebo
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obstructive Sleep Apnea; Anesthesia Recovery Period