Low-dose flunitrazepam for conscious sedation for EGD: a randomized double-blind placebo-controlled study.
BACKGROUND
EGD with conscious sedation is a safe procedure, but complications such as hypoxia can occur. The efficacy and safety of low-dose flunitrazepam (0.25 mg) was compared with a standard dose of flunitrazepam (0.5 mg) for moderate sedation during EGD.


METHODS
In a randomized, double-blind, placebo-controlled trial, 75 outpatients (40 men, 35 women, mean age 45 [11] years) undergoing screening EGD were randomly assigned to one of 3 treatment arms: 0.25 mg of flunitrazepam (F0.25 group), 0.5 mg of flunitrazepam (F0.5 group), or placebo (normal saline solution), each administered intravenously. Patient tolerance was scored by using self-assessment questionnaires with visual analogue scales. Cardiopulmonary complications were assessed by monitoring blood pressure, heart rate, oxygen saturation, and the electrocardiogram during the procedure.


RESULTS
The patient tolerance scores in the F0.25 and F0.5 groups, respectively 2.1 (2.1) and 2.3 (2.5), were significantly lower than that for the placebo group (6.5 [3.0]); there was no significant difference between F0.25 and F0.5. Cardiopulmonary complications in the F0.25 group were significantly lower than in the F0.5 group. Oxygen desaturation (oxygen saturation < 90%) was noted in two of 25 patients in the F0.5 group. Post-procedure drowsiness was observed in two of 24 (8.3%) patients in the F0.25 group and 3 of 21 (14.3%) in the F0.5 group (p = 0.2438).


CONCLUSIONS
Patient tolerance of EGD with low-dose flunitrazepam (0.25 mg intravenously) was similar to that with a standard dose (0.5 mg intravenously) and significantly better than in the placebo group. Oxygen desaturation was observed only in the group that received the standard dose, suggesting that sedation with low-dose flunitrazepam is efficacious and safe for EGD.
Yoshizawa
Takashi
T
Department of Gastroenterology and Division of Pharmacy, Juntendo University, School of Medicine, Tokyo, Japan.
Miwa
Hiroto
H
Kojima
Takayo
T
Kawakubo
Yoshiaki
Y
Namihisa
Akihiro
A
Ohtaka
Keiichi
K
Ohkura
Ryuichi
R
Nishira
Youko
Y
Toriumi
Eiko
E
Nishira
Teruo
T
Sato
Nobuhiro
N
D014151:Anti-Anxiety Agents / Q000008:administration & dosage*; D001794:Blood Pressure; D016292:Procedural Sedation; D004311:Double-Blind Method; D016145:Endoscopy, Digestive System; D005445:Flunitrazepam / Q000008:administration & dosage*; D006339:Heart Rate; D006801:Humans; D010100:Oxygen / Q000097:blood; D011446:Prospective Studies
D014151:Anti-Anxiety Agents; D005445:Flunitrazepam; D010100:Oxygen