跳至主要内容
临床试验/NCT06414018
NCT06414018已完成不适用

Effect of Equivalent Dose of Alfentanil and Sufentanil Combined With Remimazolam in Complex Bronchoscopic Treatment

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月20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
入组人数
80
试验地点
1
主要终点
time of Recovery

研究概览

简要总结

The equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients

详细描述

Afentanil is a powerful, fast-acting narcotic analgesic, which can effectively inhibit intubation reflex. Compared with sufentanil, it has a short half-life and is safer, and can be used as the first choice for short surgical analgesics. In this study, by comparing the use of equivalent dose sufentanil and afentanil combined with laryngeal mask for complex bronchoscopy, the intraoperative analgesic effect and the influence on the recovery of patients were observed, and a better anesthesia scheme was provided for tracheoscopy.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80,
  • ASA I-III level;
  • BMI 18.5~23.9;

排除标准

  • Patients with full stomach and high risk of reflux aspiration;
  • Allergic to benzodiazepines, opioids, rocuronium bromide;
  • Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
  • Pregnant and lactating women;
  • severe liver and kidney dysfunction;
  • Patients with severe anemia and hypoproteinemia;
  • Previous drug use history;
  • Recently participated in other clinical studies;
  • Patients who cannot cooperate with communication.

研究组 & 干预措施

Alfentanil

Experimental

The dose of aifentanil group is 10μg/kg

干预措施: Alfentanil (Drug)

Sufentanil group

Experimental

The dose of sufentanil group is 0.2μg/kg

干预措施: Alfentanil (Drug)

结局指标

主要结局

time of Recovery

时间窗: 1day

the time from the end of surgery to awake of patient

次要结局

  • Time records(1 day)
  • dose of drugs(1 day)
  • rate of respiratory suppression incidence(1 day)
  • rate of Incidence of Treatment-Emergent Adverse Events(1day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

aijun xu

clincal doctor

Tongji Hospital

研究点 (1)

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