NCT05760534已完成4 期
Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia - a Phase 4 Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative respiratory depression
研究概览
简要总结
This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia
- •American Society of Anesthesiologists (ASA) classification I, II, III
排除标准
- •Patient refusal
- •Contraindication for spinal anesthesia
- •Contraindication for remimazolam infusion
- •History of hypersensitivity to remimazolam
- •History of chronic use of benzodiazepine or opioid
- •Baseline MOAA/S score of 4 or lower
- •Pregnancy
研究组 & 干预措施
Ideal body weight group
Experimental
干预措施: Remimazolam (Drug)
Total body weight group
Active Comparator
干预措施: Remimazolam (Drug)
结局指标
主要结局
Incidence of intraoperative respiratory depression
时间窗: From entrance to exit from the operating room
Incidence of intraoperative respiratory depression
次要结局
- Incidence of intraoperative oxygen desaturation(From entrance to exit from the operating room)
- Incidence of intraoperative nausea or vomiting(From entrance to exit from the operating room)
- Incidence of intraoperative hypotension(From entrance to exit from the operating room)
- Intraoperative Patient State Index (PSi)(From entrance to exit from the operating room)
- Length of stay at the post-anesthesia care unit (PACU)(From entrance to exit from the PACU)
- Incidence of intraoperative tachycardia(From entrance to exit from the operating room)
- Incidence of postoperative hypotension(From entrance to exit from the PACU)
- Incidence of postoperative hypertension(From entrance to exit from the PACU)
- Total remimazolam infusion dose(From start to end of remimazolam infusion)
- Incidence of intraoperative hypertension(From entrance to exit from the operating room)
- Incidence of intraoperative bradycardia(From entrance to exit from the operating room)
- Incidence of intraoperative hiccups(From entrance to exit from the operating room)
- Incidence of intraoperative paradoxical movements(From entrance to exit from the operating room)
- Time to reach MOAA/S score 5 after end of surgery(From end of remimazolam infusion until time of full alertness)
- Patient satisfaction(At exit from PACU)
- Intraoperative recall(At exit from PACU)
- Incidence of postoperative nausea or vomiting(From entrance to exit from the PACU)
- Incidence of postoperative respiratory depression(From entrance to exit from the PACU)
- Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score(From start of remimazolam infusion until time of full alertness)
- Incidence of postoperative delirium(From end of surgery to third postoperative day)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital
研究点 (1)
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