Efficacy and Safety of Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 188
- 主要终点
- Injection pain
研究概览
简要总结
Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy.
详细描述
In this study, we found that sedation success rate was 100% in both ciprofol group and propofol group during the painless hysteroscopy. The incidence rate of injection pain and the intensity of pain in the ciprofol group were significantly lower than the propofol group. Also, the ciprofol group had lower incidence rate and severity level of adverse events and higher patient satisfaction. In addition, SBP, DBP, and MAP values in propofol group were found to be significantly lower than those in ciprofol group at the time of cervical dilation and of consciousness recovery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years old;
- •undergoing hysteroscopy examination and requiring intravenous anesthesia;
- •American Society of Anesthesiologists (ASA) physical status I to II;
- •without communication difficulties, and able to cooperate with intervention implementation;
- •participating in this trial voluntarily, and signing an informed consent form;
排除标准
- •with contraindications for hysteroscopy examination (such as cervical stenosis, difficulty in cervical dilation, reproductive tract infections such as vaginitis and cervicitis) or allergies to the intended anesthetic drugs;
- •with severe cardiac insufficiency, liver and kidney dysfunction, and other major diseases;
- •with a history of uterine surgery within the past three months;
- •body temperature above 37.5 ℃ before the anesthesia;
- •long-term use of sedative or analgesic drugs.
研究组 & 干预措施
Ciprofol group (ciprofol combined with alfentanil)
干预措施: Ciprofol (Drug)
Propofol group (propofol combined with alfentanil)
干预措施: Propofol (Drug)
结局指标
主要结局
Injection pain
时间窗: 24 hours within hysteroscopy
The injection pain was defined as the pain reported verbally by patients during the first injection of the investigational drugs (ciprofol or propofol). The Numerical Rating Scale (NRS) was used to evaluate the pain level. The anesthesiologist asks the patient during the first injection of the investigational drug (ciprofol or propofol), "Do you feel arm pain from the injection? Patients who answered "yes" was asked to describe the level of the pain (a score of 0 to 10 indicated "painless" to "unbearable pain"). The pain level was divided into painless (0 points), mild pain (1-3 points), and moderate to severe pain (4-10 points).
次要结局
- recovery time(24 hours within hysteroscopy)
- adverse events(24 hours within hysteroscopy)
- Anesthesia success rate(24 hours within hysteroscopy)
- time for successful anesthesia induction(24 hours within hysteroscopy)
- Sedation success rate(24 hours within hysteroscopy)
- use of rescue drugs(24 hours within hysteroscopy)
- times of supplementing ciprofol or propofol(24 hours within hysteroscopy)
- comparison of vital signs before and after administration(24 hours within hysteroscopy)
- severity level of adverse events(24 hours within hysteroscopy)
- patient satisfaction(24 hours within hysteroscopy)
研究者
Lei Zhu
Chief Physician
Baoding First Central Hospital