Delayed Emergence From Anesthesia, Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, General Anesthesia, Modafinil
Brief summary
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.
Detailed description
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.
Interventions
DRUGModafinil
Atypical Psychomotor stimulant
DRUGPlacebo
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Computer generated randomization list, subject, clinical team and research team blinded to intervention
Intervention model description
double blind randomized placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Meets diagnostic criteria for obstructive sleep apnea 3. Willing and able to comply with study procedures 4. Willing and able to provide informed consent 5. If female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) for one month after surgery and discontinuation of study medication (modafinil may reduce the effectiveness of steroidal contraception for one month after discontinuation)
Exclusion criteria
1. Have a medical condition that, in the study physician's judgment, may interfere with safe participation (active cardiac conditions such as angina, recent myocardial infarction w/in 6 months, severe renal or liver disease, unstable diabetes, or elevated liver enzymes greater than twice normal). 2. Have a current neurological disorder (e.g. organic brain disease, dementia) or major psychiatric condition that would impair the collection of data (schizophrenia, bipolar illness). 3. Currently on prescription medication that is known to interact with the study drug. (ethinylestradiol and triazolam). 4. Have current dependence on cocaine, methamphetamine, alcohol or benzodiazepines (DSM-IV criteria). 5. Have a history of severe valvular heart disease, severe left ventricular hypertrophy, cardiac arrhythmias, angina, cardiac syncope, or pre-syncope or myocardial infarction \<6 months. 6. Have a history of uncontrolled or poorly controlled essential hypertension, or a heart rate greater than 70% of the maximum heart rate expected for their age (Formula: 0.70(220 - age). 7. Any condition, in the opinion of the principal investigators that would compromise patient safety. 8. A documented history of sensitivity to modafinil. 9. Current Modafinil use for daytime somnolence associated with obstructive sleep apnea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit | 24 hours | Length of time of above compared between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postanesthesia Quality Recovery Scale Score | baseline and 6 hours after surgery | 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. |
Countries
United States
Participant flow
Pre-assignment details
16 patients violated the study protocol and were excluded from the study. Exclusions included Day of Surgery refusal of study medication, surgical case cancellation, and surgeon refusal to participate.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Administered Placebo day of surgery immediately prior to general anesthesia and surgery
Placebo | 42 |
| Modafinil Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery
Modafinil: Atypical Psychomotor stimulant | 47 |
| Total | 89 |
Baseline characteristics
| Characteristic | Modafinil | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 13 | 55 years STANDARD_DEVIATION 13 | 56.0 years STANDARD_DEVIATION 13 |
| Body Mass Index (BMI) | 44.9 kg/m^2 STANDARD_DEVIATION 11.6 | 41.9 kg/m^2 STANDARD_DEVIATION 11.3 | 38.2 kg/m^2 STANDARD_DEVIATION 11.1 |
| History of Delayed Emergence | 0 Participants | 0 Participants | 0 Participants |
| Hypertension | 33 participants | 59 participants | 26 participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 24 Participants | 43 Participants | 19 Participants |
| Sex: Female, Male Male | 23 Participants | 46 Participants | 23 Participants |
| Surgery Type abdominal surgey | 30 Participants | 57 Participants | 27 Participants |
| Surgery Type gynecology | 7 Participants | 11 Participants | 4 Participants |
| Surgery Type opthalmology | 0 Participants | 1 Participants | 1 Participants |
| Surgery Type orthopedic surgery | 5 Participants | 7 Participants | 2 Participants |
| Surgery Type otolaryngology | 5 Participants | 13 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 47 |
| other Total, other adverse events | 0 / 42 | 0 / 47 |
| serious Total, serious adverse events | 0 / 42 | 0 / 47 |
Outcome results
Primary
Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit
Length of time of above compared between groups
Time frame: 24 hours
Population: 16 participants violated the study protocol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit | 53.5 minutes |
| Modafinil | Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit | 61.0 minutes |
Secondary
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
Population: 16 patients violated study protocol and were excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Postanesthesia Quality Recovery Scale Score | -5.67 units on a scale | Standard Deviation 4.74 |
| Modafinil | Postanesthesia Quality Recovery Scale Score | -8.91 units on a scale | Standard Deviation 7.98 |