Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Obesity Weight Loss, Pulmonary, Pulmonary |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/6/2018 |
| Start Date: | August 2011 |
| End Date: | January 2016 |
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.
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.
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.
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.
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
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