Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions in Gynecological Laparoscopic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Mean arterial pressure (MAP) during Induction of anesthesia
研究概览
简要总结
At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.
The main questions it aims to answer are:
- whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;
- whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.
Participants will:
- Induction of anesthesia with the experimental drug or placebo；
- 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；
- To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40~60 years old；
- •ASA Class I to II；
- •The operation time was 1h~2h；
- •BMI 18~25；
- •Sign informed consent.
排除标准
- •Known allergy to narcotic drugs used in this study;
- •Severe pulmonary insufficiency;
- •Abnormal liver and kidney function；
- •History of severe anemia and hematoporphyrin；
- •History of asthma;
- •Uncontrolled high blood pressure or diabetes;
- •Pregnant and lactating women；
- •Accompanied by cognitive impairment or inability to communicate.
研究组 & 干预措施
amobarbital-propofol group
Participants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following.
干预措施: Amobarbital (Drug)
amobarbital-propofol group
Participants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following.
干预措施: Propofol (Drug)
propofol group
The propofol group was given the same volume of normal saline 1 min before induction, followed by propofol 2.5mg /kg.
干预措施: Propofol (Drug)
结局指标
主要结局
Mean arterial pressure (MAP) during Induction of anesthesia
时间窗: Up to 3 hours
MAP was recorded as the main index of hemodynamics during anesthesia induction
次要结局
- MAP at different time points(Up to 3 hours)
- Incidence of postoperative nausea and vomiting (ponv)(24 hours)
研究者
Xuebi Tian
Clinical Professor
Tongji Hospital