Efficacy of low and standard midazolam doses for gastroscopy. A randomized, double-blind study.
OBJECTIVE
To evaluate the efficacy and safety of two different doses of intravenous midazolam (35 and 70 microg/kg) compared to placebo in patients undergoing gastroscopy.


METHODS
Sixty patients scheduled for diagnostic gastroscopy were selected according to factors previously reported to affect tolerance (Eur J Gastroenterol Hepatol 1999; 11:201-204) and were randomly assigned to receive premedication with midazolam 35 microg/kg iv, midazolam 70 microg/kg iv or placebo iv. Oxygen saturation was continuously monitored during the procedure. Patients' tolerance, time to discharge and post-sedative inconvenience were evaluated using visual analogue scales and a questionnaire.


RESULTS
Patients receiving either dose of midazolam showed better tolerance of gastroscopy than those receiving the placebo. Fewer patients receiving 70 or 35 microg/kg of midazolam were reluctant to undergo a further gastroscopy compared to those receiving the placebo (2, 1 and 9 patients respectively, P = 0.01). Compared to patients receiving midazolam 70 microg/kg, those receiving midazolam 35 microg/kg were discharged earlier (29.3+/-14.4 versus 43.1+/-12.4 min respectively, P < 0.001), experienced less post-sedative inconvenience (8 versus 15 patients slept for > 1 h at home respectively, P = 0.02), and suffered fewer clinically relevant desaturation episodes (< 90%) (0 versus 5 patients respectively, P = 0.04).


CONCLUSIONS
Low doses of intravenous midazolam (35 microg/kg) are adequate and safe when sedation is indicated for gastroscopy.
Campo
R
R
Digestive Endoscopy Unit (SDI), CS Parc Tauli, Sabadell, Spain. rcampo@cspt.es
Brullet
E
E
Montserrat
A
A
Calvet
X
X
Donoso
L
L
Bordas
J M
JM
D000328:Adult; D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D005773:Gastroscopy; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D007275:Injections, Intravenous; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D008875:Middle Aged; D011292:Premedication; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D006993:Hypnotics and Sedatives; D008874:Midazolam