Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery in Patients Undergoing Thoracoscopic Lobectomy : a Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Hemodynamic fluctuations: mean blood pressure (MAP)
研究概览
简要总结
To study the Effect of Ciprofol Infusion for Induction and Maintenance of anesthesia on Hemodynamics and Postoperative Recovery in Patients Undergoing Thoracoscopic Lobectomy:a randomized, controlled trial.
详细描述
Patients undergoing Thoracoscopic Lobectomy aged 18~65 years old were randomly assigned to Group P and Group C . Group P was given propofol 2 ~ 2.5mg/kg, group C was given ciprofol 0.4 ~ 0.5mg/kg, if bispectral index(BIS) value ≤60 during anesthesia induction, cisatracurium 0.2mg/kg and sufentanil 0.5μg/kg were injected intravenously, endotracheal intubation was performed after the improvement of muscle relaxation. If the BIS value was greater than 60, propofol was added intravenously 1mg/kg each time or ciprofol 0.2mg/kg each time, and the interval of administration was greater than 1min, until BIS≤60. Cisatracurium and sufentanil were injected intravenously, followed by endotracheal intubation.Then propofol was maintained in group P at 4-12 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min .Ciprofol was maintained in Group C at 0.8-2.5 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min . Intermittent addition of cisatracurium. Sufentanil was added as required, and total dosage of Sufentanil was 0.7ug ~ 1ug/kg. BIS was kept at 40 ~ 60 during the surgery, and infusion drugs were stopped at the end of the operation. The patients were Transfer to Postanesthesia care unit(PACU) after the operation.
The primary outcomes were the fluctuations in hemodynamic parameters during induction and the surgery. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP),heart rate (HR) and BIS values at various time points were collected.
The secondary outcome were as follows:
- The time of lose consciousness（LOC） during the induction, The Time and dosage of additional drug, and the BIS value during the induction process.
- The incidence of adverse events such as injection pain, body movement, muscle twitching, hypotension, hypertension, bradycardia or tachycardia, cough and bronchospasm during induction.
- quality of recovery 15（QOR15） score at pre-operation（Preop） 、on the first day of postoperation （POD1）and on the second day of postoperation （POD2） .
- the recovery time of consciousness (ROC）, extubation time, PACU stay time, postoperative hospital stay time.
- Incidence of postoperative nausea and vomiting, incidence of postoperative agitation and delayed recovery, and intraoperative awareness.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA)Ⅰ～Ⅱ grade;
- •18-65 years;
- •Body mass index (BMI) 20-30kg/m2 ;
- •Scheduled for thoracoscopic lobectomy under general anesthesia;
排除标准
- •Refused to participate in the clinical study;
- •Predictable airway difficulties requiring awake intubation;
- •Allergy to the drugs which were used in this study;
- •Tracheal intubation failed for twice;
- •Patients with mental diseases or consciousness disorder;
- •long-term use of sedatives or Antidepressants;
- •Patients who are participating in other clinical studies.
研究组 & 干预措施
propofol group
According to grouping，patients were premeditated with injection of Propofol 2-2.5mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, propofol 1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil.Then propofol was maintained in group P at 4-12 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min .BIS was kept at 40 ~ 60 during the surgery, and infusion drugs were stopped at the end of the operation. The patients were Transfered to Postanesthesia care unit(PACU) after the operation.
干预措施: propofol (Drug)
ciprofol group
Group C was given ciprofol 0.4 ~ 0.5mg/kg, if bispectral index(BIS) value ≤60 during anesthesia induction, cisatracurium 0.2mg/kg and sufentanil 0.5μg/kg were injected intravenously, endotracheal intubation was performed after the improvement of muscle relaxation. If the BIS value was greater than 60, ciprofol 0.2mg/kg each time, and the interval of administration was greater than 1min, until BIS≤60. Cisatracurium and sufentanil were injected intravenously, followed by endotrachealintubation.Ciprofol was maintained in Group C at 0.8-2.5 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min . Intermittent addition of cisatracurium,Sufentanil was added as required, and total dosage of Sufentanil was 0.7ug ~ 1ug/kg. BIS was kept at 40 ~ 60 during the surgery, and infusion drugs were stopped at the end of the operation. The patients were Transfered to Postanesthesia care unit(PACU) after the operation.
干预措施: ciprofol (Drug)
结局指标
主要结局
Hemodynamic fluctuations: mean blood pressure (MAP)
时间窗: during anesthesia induction，perioperative
MAP during anesthesia induction and surgery.
Hemodynamic fluctuations: Systolic blood pressure(SBP)
时间窗: during anesthesia induction，perioperative
Systolic blood pressure(SBP) during anesthesia induction and surgery.
Hemodynamic fluctuations: Diastolic blood pressure(DBP)
时间窗: during anesthesia induction，perioperative
Diastolic blood pressure(DBP) during anesthesia induction and surgery.
Hemodynamic fluctuations: Heart rate (HR)
时间窗: during anesthesia induction，perioperative
Heart rate (HR) during anesthesia induction and surgery.
次要结局
- The time of lose consciousness（LOC） during the induction(during anesthesia induction)
- Incidence of intraoperative awareness(2 hours after surgery)
- The incidence of adverse events during induction(during induction)
- quality of recovery(pre-operation, postoperation of day 1 ,postoperation of day2)
- postoperative recovery(2 hours after surgery)
研究者
Xiumei Song
professor
Qianfoshan Hospital