Safety and driving ability following low-dose propofol sedation.
OBJECTIVE
Automobile driving is prohibited after midazolam sedation because of the slow recovery of psychomotor function. This study prospectively assessed the safety of low-dose propofol sedation (study 1) and compared driving ability following propofol and midazolam sedation (study 2).


METHODS
Study 1: We prospectively investigated bolus injection of a low-dose of propofol (40-80 mg for <70 years and 30 mg for >or=70 years) for diagnostic esophagogastroduodenoscopy (EGD). Respiratory depression, time to full recovery, and overall patient satisfaction were evaluated and blood concentrations of propofol were measured. Study 2: A subset of subjects undergoing diagnostic EGD were randomized to receive 40 mg of propofol (n = 30), 4 mg of midazolam (n = 30) or no sedation controls (n = 20), and the residual effects of each drug were tested using a driving simulator. The primary outcome measure was driving ability. The second outcome measures were overall patient satisfaction and complications.


RESULTS
Study 1: Only 1.1% of 12,031 healthy subjects developed transient oxygen desaturation. Full recovery was present in 97.5% 30 min after the procedure; 99.8% were willing to repeat the same procedure. The blood levels of propofol (40-80 mg) at 60 min were <100 ng/ml. Study 2: Driving ability recovered to the basal level within 60 min of propofol administration but not with 120 min with midazolam. There were no complications; overall patient satisfaction was similar between propofol and midazolam (8.9 vs. 8.5, p = 0.34).


CONCLUSIONS
Low-dose propofol sedation was safe and recovery including driving ability was with 60 min.
Horiuchi
Akira
A
Department of Gastroenterology, Showa Inan General Hospital, Komagane, Japan. horiuchi.akira@sihp.jp
Nakayama
Yoshiko
Y
Katsuyama
Yoshihiko
Y
Ohmori
Shigeru
S
Ichise
Yasuyuki
Y
Tanaka
Naoki
N
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000009:adverse effects; D001334:Automobile Driving; D004305:Dose-Response Relationship, Drug; D016145:Endoscopy, Digestive System; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D010100:Oxygen / Q000097:blood; D017060:Patient Satisfaction; D015742:Propofol / Q000008:administration & dosage* / Q000009:adverse effects*; D011446:Prospective Studies; D012449:Safety; D013997:Time Factors; D055815:Young Adult
D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives; D008874:Midazolam; D010100:Oxygen; D015742:Propofol