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临床试验/NCT06172140
NCT06172140已完成不适用

Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy: A Prospective, Randomized, Non-inferiority Trial.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年1月1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
124
试验地点
1
主要终点
Success rate of painless hysteroscopy

研究概览

简要总结

Eligible patients undergoing hysteroscopy were randomly assigned in a 1:1 ratio to receive intravenous anesthesia with either propofol (2 mg/kg) or remifentanil (0.4 mg/kg).Continuous monitoring of pulse oximetry (SpO2), blood pressure (BP), heart rate (HR), expired gas partial pressure of carbon dioxide, integrated respiratory index (IPI), tidal volume (TV), respiratory rate (RR), and minute ventilation (MV) was performed.During induction, the MOAA/S score was assessed every 30 seconds. If the MOAA/S score remained >1, a supplementary dose of 1/2 of the initial dose was injected within 10 seconds.If more than 5 supplementary doses were required within 15 minutes, it was considered that the painless hysteroscopy failed and propofol was used to enhance sedation.Continuous oxygen administration at a flow rate of 5 liters per minute was provided through nasal catheters until the patient was fully alert with a MOAA/S score of 5 and vital signs were stable.Observation indicators included: (1) the success rate of hysteroscopy;(2) induction time (MOAA/S ≤ 1 after the first dose);(3) full recovery time of consciousness;(4) operation duration;(5) number of additional anesthetics;(6) incidence of hypotension, hypoxemia, sinus bradycardia, delayed recovery, and injection pain;(7) respiratory parameters and minimum SpO2, IPI values before anesthesia, after induction, and after awakening.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Voluntary signing of informed consent form
  • Stable vital signs and qualified anesthesia outpatient evaluation
  • No contraindications to anesthesia

排除标准

  • Not willing to sign informed consent form
  • Anaesthesia drug allergy
  • Severe central nervous system diseases
  • Severe hypertension and diabetes
  • Mental disorders
  • History of using psychotropic drugs in the past 3 months

研究组 & 干预措施

Ciprofol group

Experimental

Intravenous injection of ciprofol

干预措施: Ciprofol group (Drug)

Propofol group

Experimental

Intravenous injection of propofol

干预措施: Propofol group (Drug)

结局指标

主要结局

Success rate of painless hysteroscopy

时间窗: During procedure (The inspection is completed and the vaginal speculum is removed)

During the induction of sedation, the anaesthesiologist evaluated the MOAA/S score every 30 s. If the MOAA/S score remained \>1 after 2 min of initial administration of the study drug, a top-up dose of 1/2 the initial dose was injected over 10 s. During the maintenance phase, supplementary doses are given when the MOAA/S score is\>1, and repeated every 2 minutes as needed. If more than 5 additional doses are required within 15 minutes, it is considered a failure of painless hysteroscopy .

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)

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