Efficacy and Safety of Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation: A Double-Blind, Randomized, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sedation efficacy
研究概览
简要总结
Efficacy and Safety of Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation
详细描述
Ciprofol was injected before ablation and sedation scores were measured to make sure certain sedation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who intend to undergoing ultrasound-guided percutaneous radiofrequency ablation of liver tumors;
- •Age: 18-75 years old;
- •ASA grade I-III;
- •Laboratory examination meets the following conditions: neutrophils >1.5×109/L, platelet >80×109/L, hemoglobin >90g/L, aspartate transferase <1.5×ULN, total bilirubin <1.5×ULN, serum creatinine <1.2 x ULN;
- •Chemotherapy < 4 times.
排除标准
- •Patients who are known to be allergic to propofol, opioids, eggs, soy products, or patients who are contraindicated with these drugs or foods due to illness;
- •serious organ dysfunction and other systemic diseases, such as liver dysfunction, renal dysfunction; Worsening congestive heart failure within the last 6 months resulting in hospitalization or adjustment of medication; Severe aortic or mitral stenosis; Heart surgery (heart valve replacement) within the last 6 months; Acute myocardial infarction in the last 6 months; Hemodynamic disturbance due to arrhythmia; Respiratory diseases; Cerebrovascular diseases; . Taking propofol, opioids or other analgesic and sedative drugs 72 hours before . Emergency surgery;
- •Those who are unable to communicate with the researcher normally or who are deemed unsuitable by the researcher and refuse to participate in the study.
研究组 & 干预措施
Propofol
Use propofol for sedation during anesthesia.
干预措施: Propofol (Drug)
Ciprofol
Use ciprofol for sedation during anesthesia
干预措施: Ciprofol (Drug)
结局指标
主要结局
Sedation efficacy
时间窗: From the start of propofol/ciprofol injection to 4 min after sedation.
Satisfaction assessed by MOAAS, Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scale is a validated 6-point scale assessing responsiveness of patients coinciding with the American Society of Anesthesiologists (ASA) continuum of sedation. MOAA/S 0 to 1 represent deeper sedation, MOAA/S 2 to 3 represent moderate sedation and MOAA/S 4 to 5 represent lighter to no sedation. In this study, MOAAS between 2-3 after initial IV dosage of propofol/ciprofol was defined as efficacy sedation.
次要结局
- Respiratory depression(From the injection of propofol/ciprofol to the period patient return to the ward, an average of 2 hours.)
- Injection pain(From the injection of propofol/ciprofol to the end of the surgery, an average of 1 hour.)
研究者
Wang Jiangling
Principle Investigator
Zhejiang Cancer Hospital