Medical Student Research Fellowship for Summer 2012
Mentor: Enas Kandil, M.D.
Department: Anesthesiology and Pain Management
Room number: C2116
Phone number: 214-857-1818
Project title: The effects of Armodafinil (Nuvigil) on postoperative recovery of obstructive sleep apnea and obese patients
Human subjects IRB approved project number: 10-041
Brief Description of Project:
Nuvigil improves postoperative wakefulness in obstructive sleep apnea patients and obese patients; Nuvigil improves postoperative recovery time in obese and OSA obstructive sleep apnea patients, as measured by Ramsey score and Aldrete score compared to patients without Nuvigil (Placebo group). 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 pateints might also need to spend the night in intensive care for more frequent monitoring for any desaturation 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 the first 24 hours after surgery specifically if patient will require intravenous postoperative narcotics.
One of the most costly aspects in patient perioperative process has always been recovery time more specifically in outpatient settings where discharge criteria should be met ideally in a timely manner. This can be difficult in obese patients and patients with OSA who are sometimes not considered for outpatient surgery due to the increased risk of perioperative desaturations and hypoxia.
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. Nuvigil is the R-enantiomer of modafinil (provigil). The precise mechanism(s) through which armodafinil or modafinil (mixture of R- and S-enatiomers) promote wakefulness is unknown.
Both Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines. In addition to its wake-promoting effects and ability to increase locomotor activity in animals, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans.
Nuvigil is a longer acting product which is similar in action to Modafinil, but it is much cheaper. Nuvigil has not been previously studied for postoperative recovery. We intent to study the effects of Nuvigil on post operative recovery time and wakefulness in obstructive sleep apnea and obese patients.
Prospective Randomized, Double-blinded, placebo controlled study
Administering general anesthesia to patients with obstructive sleep apnea syndrome will decrease muscle tone and may lead to airway closing. This increases the patient's risk of decreased oxygen in blood during recovery, which translates to longer monitoring time and possible intensive care admission.
The purpose of this research is to determine if Nuvigil, an FDA approved obstructive sleep apnea drug, improves oxygenation and wakefulness after surgery.
For this study, the doctor will give the patient one dose (150mg) of Nuvigil or a medication with no active ingredient (placebo) prior to surgery in the pre-surgical room. The expected duration of participation (estimated 4-6 hours) is from taking the medication before surgery to the time the patient leaves the recovery room to be discharged or escorted to an assigned hospital bed.
The approximate number of patients in this study is 96. All patients in this study will take a pill of either Nuvigil or the placebo. The doctor giving the medication will not know which one the patient is taking.
Previous Research Activities or Publications with Medical Students: