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Trial record 11 of 239 for:    (armodafinil)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02478580
Recruitment Status : Completed
First Posted : June 23, 2015
Results First Posted : March 23, 2016
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Enas Kandil, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Obesity
Premature Recovery From Anesthesia
Interventions Drug: Nuvigil
Drug: Placebo
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nuvigil Control
Hide 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
Arm/Group Title Nuvigil Control Total
Hide 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 Number of Baseline Participants 34 33 67
Hide Baseline Analysis Population Description
Patient with obstructive sleep apnea undergoing surgery
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 67 participants
51.7  (12.7) 54.7  (10.8) 53.7  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
Female
5
  14.7%
4
  12.1%
9
  13.4%
Male
29
  85.3%
29
  87.9%
58
  86.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 33 participants 67 participants
34 33 67
1.Primary Outcome
Title Postoperative Care Unit (PACU) Recovery Time
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Patient with obstructive sleep apnea undergoing surgery
Arm/Group Title Nuvigil Control
Hide 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
Overall Number of Participants Analyzed 34 33
Mean (Standard Deviation)
Unit of Measure: Minutes
98.2  (58.2) 95  (60.7)
2.Secondary Outcome
Title The Aldrete Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nuvigil Placebo
Hide 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

Overall Number of Participants Analyzed 34 33
Mean (Standard Error)
Unit of Measure: units on a scale
9.4  (0.27) 9.3  (0.26)
Time Frame Postoperative 24-h period.
Adverse Event Reporting Description Fatigue was assessed during postoperative 24-h period.
 
Arm/Group Title Nuvigil Control
Hide 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 (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nuvigil Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nuvigil Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%) 
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.
Results Point of Contact
Name/Title: Dr. Enas Kandil
Organization: University Of Texas Southwestern Medical Center
Phone: 214-590-8509
Responsible Party: Enas Kandil, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02478580     History of Changes
Other Study ID Numbers: 10-041
First Submitted: June 8, 2015
First Posted: June 23, 2015
Results First Submitted: February 22, 2016
Results First Posted: March 23, 2016
Last Update Posted: December 4, 2018