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临床试验/NCT04563260
NCT04563260已完成不适用

Effect of Palonosetron on Effect-site Concentration of Remifentanil for Preventing Emergence Cough During General Anesthesia in Female Patients Undergoing Laparoscopic Cholecystectomy

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
optimal Ce of remifentanil

研究概览

简要总结

The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female patients who receive the palonosetron or not.

详细描述

Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

研究设计

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

入排标准

年龄范围
19 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Laparoscopic cholecystectomy under general anesthesia

排除标准

  • BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension

研究组 & 干预措施

Control group

Placebo Comparator

Control group receives the intravenous normal saline 2 mL.

干预措施: Normal saline injection (Drug)

Palonosetron group

Experimental

Palonosetron group receives the intravenous palonosetron 1.5 mL (0.075 mg) + normal saline 0.5 mL.

干预措施: Palonosetron Injection [Aloxi] (Drug)

结局指标

主要结局

optimal Ce of remifentanil

时间窗: From the end of surgery until the time of endotracheal extubation, about 20 minutes

Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia

次要结局

未报告次要终点

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Eun Kim

associate professor

Ajou University School of Medicine

研究点 (1)

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