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Remimazolam vs. midazolam sedation in upper gastrointestinal endoscopy in adults ≥ 65 years : Randomized controlled trial

초록/요약

Purpose: Safe and effective sedation are important factors when performing gastrointestinal endoscopy. However, clinicians should be cautious when using sedatives in older patients because of their decreased physiological reserves. Remimazolam is an ultrashort active benzodiazepine that has attracted attention because of its efficacy. This study aimed to determine the safety and efficacy of remimazolam compared with midazolam as a sedative for diagnostic upper gastrointestinal endoscopy in older patients aged ≥65 years. Methods: We randomly assigned patients aged ≥65 years who were scheduled for diagnostic upper gastrointestinal endoscopy. The average induction time, average recovery time, and side effect profile of patients who received remimazolam as a sedative were compared with those of patients who received midazolam. Results: A total of 120 patients underwent randomization (60 in the remimazolam group and 60 in the midazolam group). Patients who received remimazolam had shorter average induction (mean  standard deviation, 102.0  77.2 sec vs. 327.5  125.3 sec, p〈0.001) and recovery times (mean  standard deviation, 5.8  3.1 min vs. 13.4  7.8 min, p〈0.001) than those who received midazolam. No significant difference in side effect profiles was observed between the groups. Conclusions: In performing upper gastrointestinal endoscopy in older patients, remimazolam can be a good alternative sedative to midazolam, whether used as monotherapy or in combination therapy.

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목차

1. INTRODUCTION 1
2. MATERIAL AND METHODS 3
2.1. Study design and patients 3
2.2. Upper gastrointestinal endoscopy under sedation 3
2.3. Definition of evaluation variables 7
2.4. Statistical analysis 7
3. RESULTS 9
3.1. Baseline characteristics of the remimazolam and midazolam groups 9
3.2. Comparison of induction and recovery time between remimazolam and midazolam 10
3.3. Comparison of sedation induction and recovery time between midazolam and remimazolam groups in cases of successful sedation 12
3.4. Adverse events and subjective variables 14
4. DISCUSSION 16
References 20

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