Premedication with orally administered midazolam in adults undergoing diagnostic upper endoscopy: a double-blind placebo-controlled randomized trial

• Published in: Gastrointestinal endoscopy 2005-02, Vol.61 (2), p.195-200
• Main Authors: Mui, Lik-man, Teoh, Anthony Y.B., Ng, Enders K.W., Lee, Yuk-tong, Au Yeung, Alex C.M., Chan, Yuk-ling, Lau, James Y.W., Chung, S.C. Sydney
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Anesthesia; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Anti-Anxiety Agents - administration & dosage; Anxiety - etiology; Anxiety - prevention & control; Biological and medical sciences; Conscious Sedation; Digestive system. Abdomen; Disorders of higher nervous function. Focal brain diseases. Central vestibular syndrome and deafness. Brain stem syndromes; Double-Blind Method; Endoscopy; Endoscopy, Gastrointestinal - adverse effects; Endoscopy, Gastrointestinal - methods; Female; General anesthesia. Technics. Complications. Neuromuscular blocking. Premedication. Surgical preparation. Sedation; Humans; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Midazolam - administration & dosage; Nervous system (semeiology, syndromes); Neurology; Premedication; Prospective Studies
• ISSN: 0016-5107; 1097-6779
• DOI: 10.1016/S0016-5107(04)02590-8

A double-blind placebo-controlled randomized trial was conducted to investigate the safety and the efficacy of orally administered midazolam as premedication for patients undergoing elective EGD. A total of 130 patients were randomized to receive either 7.5 mg of midazolam orally (n = 65) or a placebo (n = 65) as premedication. Outcomes measures included the anxiety score (visual analog scale) during EGD, overall tolerance, extent of amnesia, overall satisfaction, patient willingness to repeat the procedure, recovery time, and hemodynamic changes after medication. The median (interquartile range) anxiety score during the procedure in the midazolam group was significantly lower than that in the control group (2.0 [0-4.9] vs. 3.8 [2.1-7.95], p < 0.001). A significantly greater number of patients in the midazolam group graded overall tolerance as “excellent or good” (70.8% vs. 49.2%, p = 0.012) and reported a partial to complete amnesia response (52.3% vs. 32.3%, p = 0.02) when compared with the control group. Patients in the midazolam group were more willing to repeat the procedure if necessary (89.2% vs. 69.2%, p = 0.005). The median (interquartile range) recovery time was significantly longer in the midazolam group than in the control group (5 [5-15] minutes vs. 5 [5-10] minutes, p = 0.014). There were no statistically significant differences in satisfaction score and hemodynamic changes between groups. Premedication by oral administration of midazolam is a safe and an effective method of sedation that significantly reduces anxiety and improves overall tolerance for patients undergoing EGD.