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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02478580
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arms: 2
• Actual Duration (Months): 53
• Patients Per Site Per Month: 1.3

Study Details

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
• 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: Aug 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Jan 1, 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 Names: Armodafinil
Placebo Comparator: Placebo A single oral placebo will be given in preoperative area	Drug: Placebo; Placebo will be given before surgery; Other Names: Oral placebo

Outcome Measures

Primary Outcome Measures

1. Postoperative Care Unit (PACU) Recovery Time [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enas Kandil, Medical Doctor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02478580
• Other Study ID Numbers: 10-041
• First Posted: Jun 23, 2015
• Last Update Posted: Dec 4, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Enas Kandil, Medical Doctor, University of Texas Southwestern Medical Center: Obstructive Sleep Apnea; Anesthesia Recovery Period
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Modafinil

Study Results

Participant Flow

Arm/Group Title	Nuvigil	Control
Arm/Group Description	A single oral dose of Nuvigil 150mg in preoperative area NUVIGIL: Patient will receive Nuvigil before the surgery	Placebo in preoperative area Patient will receive placebo before the surgery
Period Title: Overall Study
STARTED	34	33
COMPLETED	34	33
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Nuvigil	Control	Total
Arm/Group Description	A single oral dose of Nuvigil 150mg in preoperative area NUVIGIL: Patient will receive Nuvigil before the surgery	Placebo in preoperative area	Total of all reporting groups
Overall Participants	34	33	67
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.7 (12.7)	54.7 (10.8)	53.7 (11.8)
Sex: Female, Male (Count of Participants)
Female	5 14.7%	4 12.1%	9 13.4%
Male	29 85.3%	29 87.9%	58 86.6%
Region of Enrollment (participants) [Number]
United States	34 100%	33 100%	67 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patient with obstructive sleep apnea undergoing surgery

Arm/Group Title	Nuvigil	Control
Arm/Group Description	A single oral dose of Nuvigil 150mg in preoperative area NUVIGIL: Patient will receive Nuvigil before the surgery	Placebo in preoperative area
Measure Participants	34	33
Mean (Standard Deviation) [Minutes]	98.2 (58.2)	95 (60.7)

2. Secondary Outcome

Title	The Aldrete Score
Description	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.
Time Frame	2 hours after extubation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nuvigil	Placebo
Arm/Group Description	A single oral dose of Nuvigil at 150mg dose in preoperative area	A single oral placebo will be given in preoperative area Nuvigil: Patients will receive Nuvigil before the surgery
Measure Participants	34	33
Mean (Standard Error) [units on a scale]	9.4 (0.27)	9.3 (0.26)

Adverse Events

Time Frame	Postoperative 24-h period.
Adverse Event Reporting Description	Fatigue was assessed during postoperative 24-h period.
Arm/Group Title	Nuvigil		Control
Arm/Group Description	A single oral dose of Nuvigil 150 mg in preoperative area NUVIGIL: Patient will receive Nuvigil before the surgery		Placebo in preoperative area Patient will receive placebo before the surgery
All Cause Mortality
	Nuvigil		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)
Serious Adverse Events
	Nuvigil		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Nuvigil		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.