跳至主要内容
临床试验/NCT05736341
NCT05736341已完成不适用

Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

Yonsei University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年5月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
intraoperative nausea and vomiting during sedative period

研究概览

简要总结

Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, high-level blockage or hypotension induced by this technique may induce intraoperative nausea and vomiting (IONV), which is associated with patient discomfort and protrusion of abdominal viscera which may adversely affect patient safety. To prevent IONV, midazolam is frequently administered after delivery, but risk of hypotension and prolonged sedation due to its active metabolite also increases. On the other hand, remimazolam is known to have relatively shorter half-life and less likely induce hypotension when compared to midazolam, yet its effect on IONV has not been thoroughly evaluated. Hence, this study aimed to compare the effects of remimazolam and midazolam in preventing IONV in patients scheduled for elective Cesarean section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients (age ≥ 20yrs and ASA Class II or III) who are scheduled for elective Cesarean section

排除标准

  • Emergency surgery Patients who are diagnosed preeclampsia or eclampsia, BMI ≥ 40kg/m2, IUP < 36 weeks Patients with contraindications to spinal anesthesia Patients who do not want sedation during the procedure

研究组 & 干预措施

Remimazolam

Experimental

Patient group who receives remimazolam for sedation after delivery

干预措施: Remimazolam besylate (Drug)

Midazolam

Active Comparator

Patient group who receives midazolam for sedation after delivery

干预措施: Midazolam (Drug)

结局指标

主要结局

intraoperative nausea and vomiting during sedative period

时间窗: at the end of surgery

Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Comparison of Remimazolam and Midazolam for... | 临床试验