Propofol EC50 for Inducing Loss of Consciousness in Gastrectomy: Combined General and Epidural Anesthesia Versus General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Propofol EC50 for Inducing Loss of Conciousness
研究概览
简要总结
The beneficial of perioperative usage of thoracic epidural anesthesia and analgesia in various thoracic and upper abdominal surgery are well studied. However, intraoperative data are lacking whether combined thoracic epidural and general anesthesia have effect on the median (50%) effective effect-concentration (EC50) of propofol for inducing loss of consciousness (LOC). We performed this study among patients undergoing open gastrectomy in gastric cancer patients.
Sixty patients undergoing open gastrectomy were randomly assigned to two groups with thoracic combined general anesthesia (TEA+GA) or general anesthesia (GA) alone. Target-controlled infusion (TCI) of propofol was used for anesthesia induction. The initial propofol concentration of target effect-site (Ceprop) was 3.5 ug/ml and was increased stepwise by 0.5ug/ml at each 4 min intervals by an un-down sequential method to reach LOC. The predicted Ceprop at the time of LOC, intravenous anesthetics, vasopressor requirement, emergency time from anesthesia and postoperative numeric rating scale (NRS) were recorded and analyzed between two groups.
详细描述
After received the approvement of ethics committee of the Cancer Hospital of the University of Chinese Academy of Sciences (approval number IRB- 2021-214). 60 adult gastric cancer patients between 18-75 yrs, ASA physical state I and II, undergoing open gastrectomy, were enrolled in this study. The exclusion criteria included: patients with contraindications to epidural puncture or catheter placement; chronic or acute (within 48 h) intake of psychotropic drugs, benzodiazepines, anticonvulsants, or opioids; alcoholism; hepatic, renal, neurological or other organ dysfunction; younger than 18 years or older than 75 years; with allergic to local anesthetic solutions or opioids; received neo-adjuvant chemotherapy; as well as patients who refuse to receive epidural puncture.
Patients were randomly assigned to either TEA+GA group of GA group. The requirement for the modified up-down method was used to confirm sample size (1).
Preoperative arrangements 3-lead electrocardiogram, pulse oximetry and continuously invasive artery blood pressure via left radial artery() were measured for basic monitoring. A central venous catheter was placed in the right internal jugular vein for fluid input and central venous pressure measurement and its position was confirmed by ultrasound. Bispectral Index (BIS) monitor (VT94306, Aspect VISTA, Covidien IIc, MA, USA) was measured for monitoring the depth of anesthetic.
Thoracic Epidural Anesthesia Epidural puncture was performed in the left lateral position through the interspace between the eighth to ninth thoracic vertebra (T8-T9). Epidural catheter was inserted by median approach using "loss-of-resistance"technique and was placed advanced 4 cm cephalad. A test dose of 3ml, 1%, lidocaine was injected through the catheter after the aspiration test for blood and cerebrospinal fluid shows negative results. Non sensory and motor anesthesia after 4 min of test dose injection indicate the absence of accidental subarachnoid placement of the catheter. In group TEA+GA, 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction, by the second anesthesiologist, to obtain a bilateral segmentary sensory block to pinprick between T4 and T12 dermatomes. Continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction(2). In group GA, same dose of normal saline was administered before induction and during surgery.
General Anesthesia General anesthesia was induced by propofol plasma target-controlled infusion (TCI) (). To explore the EC50 of propofol for inducing LOC in two groups. We started induction using a series of predicted effect-site concentrations of propofol (Ceprop) with an equal step wise of 0.5 ug/ml, according to the up-down method of Dixon(1). The initial Ceprop for the first patient of each group was 3.5 ug/ml based on previous studies (3) . Positive response to propofol was defined as LOC happened within 4 min after start of TCI under initial concentration. Otherwise the response was taken as negative and propofol concentration was increased 0.5 ug/ml more each 4 min until patient reach LOC (LOC was defined as loss of response to verbal commands). The initial TCI Ceprop was increased by 0.5 ug/ml for the next patients if the previous patient shows negative in the same group. The initial TCI Ceprop was decreased by 0.5 ug/ml for the next patient if the previous patient shows positive in the same group. All the patients were increased by 0.5 ug/ml stepwise at 4 min intervals until they showed LOC. An interval of 4 min was based on the pharmacokinetic and pharmacodynamic (PK-PD) character of propofol in order to obtain the steady-state effect-site concentrations (4; 5). An intravenous of 0.25 mg/Kg oxycodone and 0.6 mg/Kg rocuronium were given after LOC to facilitate tracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Epidural puncture was performed by the fist anesthesiologist. First dosage and continuous infusion of ropivacaine was administered by the second anesthesiologist.
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
- •Gastric cancer patients age between 18-75 yrs;
- •ASA physical state I and II
- •Undergoing open gastrectomy
排除标准
- •With contraindications to epidural puncture or catheter placement
- •Chronic or acute (within 48 h) intake of psychotropic drugs, benzodiazepines, anticonvulsants, or opioids; alcoholism
- •Hepatic, renal, neurological or other organ dysfunctiony
- •Younger than 18 years or older than 75 years
- •Allergic to local anesthetic solutions or opioids
- •Received neo-adjuvant chemotherapy
- •Refuse to receive epidural puncture
研究组 & 干预措施
Combined epidural with general anesthesia
Patients in this group received 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction.Followed by a continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction during surgery.
干预措施: 5-8ml 0.375% ropivacaine (Drug)
General anesthesia
In this group, same dose of normal saline was administered before induction and during surgery.
干预措施: 5-8ml normal saline (Other)
结局指标
主要结局
Propofol EC50 for Inducing Loss of Conciousness
时间窗: From anesthesia induction to patient loss of consciousness, an average of 5 minutes.
Recording propofol EC50 for inducing loss of conciousness between general with epidural anesthesia group and general group with propofol effect-site target-controlled infusion (TCI) system
Predicted Effect-site Concentration of Propofol (Ceprop) at Certain Time Points
时间窗: From anesthesia induction to the patient loss of consciousness, an average of 5 minutes.
Recording the effect-site concentration of propofol (Ceprop) which showed on target-controlled infusion (TCI) system at loss of consciousness and discontinuation of anesthetics
次要结局
- Postoperative Exhaust Time(0-14 days postoperatively)
- Anesthetics Consumption(From anesthesia induction to the end of surgery, an average of 2.5 hours.)
研究者
Wang Jiangling
Clinical Resident
Zhejiang Cancer Hospital
