Incidence of Respiratory Depression of Remimazolam Compared With Propofol for Monitored Anesthesia Care During Hysteroscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Respiratory insufficiency before surgery
研究概览
简要总结
The comparison of incidence of respiratory depression between remimazolam and propofol under monitored anesthesia care for hysteroscopic surgery
详细描述
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Non-invasive blood pressure, electrocardiogram, and oxygen saturation sensors are attached.
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Wear an oxygen mask (5L per minute), and place the sampling line for end-tidal carbon dioxide partial pressure measurement inside the nose.
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Check the randomization table to determine the drug to be administered, and prepare propofol or remimazolam accordingly.
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Record the baseline values (0 min).
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Start administration of Remifentanil.
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, Investigator)
盲法说明
Care giver will notice which drug will be given to the patients because of the color (White vs clear) and infusion doses of the drugs.
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA PS 1-2
- •Elective hysteroscopic surgery under monitored anesthesia care
- •No drug abuse history
排除标准
- •BMI > 30 kg/m2
- •Hepatic or renal insufficiency
- •Alcohol abuse
- •Respiratory, hemodynamic compromise, or diseases
- •History of general/regional anesthesia during the last month
- •A patient who is taking sedatives or analgesics
- •Under the investigator's judgment
研究组 & 干预措施
Propofol group
Propofol infusion with remifentanil for hysteroscopic surgery
干预措施: Propofol (Drug)
Remimazolam group
Remimazolam infusion with remifentanil for hysteroscopic surgery
干预措施: Remimazolam (Drug)
结局指标
主要结局
Respiratory insufficiency before surgery
时间窗: From the beginning of drug infusion until the moment of starting surgery (assessed up to 30 minutes)
Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96%
Respiratory insufficiency during surgery
时间窗: From the beginning of the surgery until the end of the drug infusion (assessed up to 60 minutes)
Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96%
次要结局
- Pain on injection(Just after the beginning of drug infusion)
- Hypertension(Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes)
- Hypotension(Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes)
- Bradycardia(Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes)
- Tachycardia(Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes)
- Maximum ETCO2(Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes)
- Patient satisfaction with Monitored Anesthetic Care(Just before leaving the recovery room)
- Postoperative Nausea/Vomiting (PONV)(During staying at the recovery room (up to 60 minutes))
研究者
Junyong In, MD, PhD
Professor
DongGuk University