Abstract
Introduction: To investigate the safety and efficacy of oral midazolam as premedication for patients undergoing upper GI endoscopy, A double blind placebo controlled randomized trial was conducted.
Methods: A total of 150 patients were randomized to receive either 7.5 mg oral midazolam (n = 75) or a placebo (n = 75) as premedication in patients undergoing upper GI endoscopy. Primary outcome measure was anxiety score (visual analog scale) during procedure. Secondary outcome measures were overall tolerance, extent of amnesia, patient willingness to repeat the procedure and hemodynamic changes after medication.
Result: The median anxiety score during the procedure in the midazolam group was significantly lower than in the control group (1.8 vs. 3.6). A significantly higher number of patients in the midzolam group graded overall tolerance as excellent or good as compared to control group (72% vs. 48%). A significantly higher number of patients in the midazolam group reported a partial to complete amnesia response as compared to control (52% vs.32%). Patients in the midazolam group were more willing to repeat the procedure if necessary (88% vs. 64%). There was no statistically significant difference in hemodynamic changes between groups.
Conclusions: Oral administration of midazolam as premedication is safe and effective method of sedation that significantly reduces anxiety and improves overall tolerance for patients undergoing upper GI endoscopy.
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Corresponding Author
Dr Anil Sharma
Assistant Professor Gastroenterology, Govt. Medical College, Kota, India