The purpose of this study is to determine whether modafinil use in patients with obstructive sleep apnea will improve postoperative delayed emergence after general anesthesia.
This is a randomized, double blind placebo controlled evaluation of modafinil versus placebo for the treatment of general anesthesia related delayed emergence in patients with the diagnosis of obstructive sleep apnea. 124 patients will be recruited and randomized on the day of surgery to receive 200mg modafinil or placebo. After randomization, patients will proceed to the operative suite for surgical procedure under general anesthesia. The primary outcome measured will be post-anesthesia care unit length of stay. Secondary outcomes will include performance on a post-anesthesia recovery scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit
Length of time of above compared between groups
Time frame: 24 hours
Postanesthesia Quality Recovery Scale Score
Postanesthesia quality recovery scale (PQRS). Component and aggregate scoring on the scale. Measures physiology, nociceptive, emotional activities of daily living cognitive and overall patient perspective. The scale is dimensionless and the aggregate of all individually tested dimensions is scaled from 17-65. A higher value implies improved postanesthesia recovery. Mean difference was assessed in each patient and aggregated thus patients with no difference between pre- and post-operative scores were zeroed (received a zero score if the difference was zero). A negative value was associated with worse outcome.
Time frame: baseline and 6 hours after surgery
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