Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 648
- 主要终点
- Serum cystatin C (CysC) level
研究概览
简要总结
In this single center, double-blind, randomized controlled clinical trial, we will include 648 diabetes patients aged 18-70 undergoing laparoscopic pelvic tumor resection. They will be randomized to the following four groups: high-pressure pneumoperitoneum (10mmHg)+ deep neuromuscular block group, high-pressure pneumoperitoneum (15mmHg)+moderate neuromuscular block group, low-pressure pneumoperitoneum + deep neuromuscular block group and low-pressure pneumoperitoneum+moderate neuromuscular block group. Deep neuromuscular block is defined as post tetanic count (PTC) 1-2, and low neuromuscular block is defined as train-of-four (TOF) twitch 1-2. The outcomes will be indicators for acute kidney injury and surgical condition.
详细描述
In this single center, double-blind, randomized controlled clinical trial, we will include 648 diabetes patients aged 18-70 undergoing laparoscopic pelvic tumor resection under general anesthesia. They will be randomized to the following four groups: high-pressure pneumoperitoneum (10mmHg)+ deep neuromuscular block group, high-pressure pneumoperitoneum (15mmHg)+moderate neuromuscular block group, low-pressure pneumoperitoneum + deep neuromuscular block group and low-pressure pneumoperitoneum+moderate neuromuscular block group. Neuromuscular block will be induced by rocuronium bolus and maintained by a continuous infusion of rocuronium. Deep neuromuscular block is defined as PTC 1-2, and low neuromuscular block is defined as train-of-four TOF twitch 1-2. The primary outcome will be serum Cystatin C level, and the secondary outcomes will be serum creatine level, urinary sediment, intraoperative urine output, duration of surgery, surgical space condition and occurrence bucking and body movement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The patients, surgeons and the ones who collect data will be masked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70;
- •American Society of Anesthesiologist physical status (ASA) II-Ⅲ;
- •Diagnosed of diabetes;
- •Undergoing elective laparoscopic pelvic tumor resection under general anesthesia;
- •Estimated duration of operation >2h;
- •Exclusion criteria:
- •Not willing to participate in the study or not able to sign the informed consent；
- •Diagnosed of other kidney diseases except diabetic nephropathy;
- •Severe renal insufficiency defined as serum creatine level > 2 times the upper limit of normal, or urine output < 0.5ml/kg/h, or estimated glomerular filtration rate < 60ml/h;
- •Severe liver, lung or heart dysfunction;
- •Known or suspect neuromuscular disease;
- •Use of drugs that may affect neuromuscular block monitoring;
- •Severe diabetic neuropathy or other peripheral neuropathy；
- •Known or suspect allergy to general anesthetics；
- •Family history of malignant hyperthermia；
- •Previous history of pelvic surgery.
排除标准
- 未提供
研究组 & 干预措施
high pressure + deep block
Intra-abdominal pressure will be set to 12-15 mmHg during the surgery. Deep neuromuscular block will be induced by rocuronium bolus 1 mg/kg, maintained by a continuous infusion of rocuronium (0.6mg/kg/h), and titrated towards post-tetanic count (PTC) 1-2.
干预措施: high pressure (Procedure)
high pressure + deep block
Intra-abdominal pressure will be set to 12-15 mmHg during the surgery. Deep neuromuscular block will be induced by rocuronium bolus 1 mg/kg, maintained by a continuous infusion of rocuronium (0.6mg/kg/h), and titrated towards post-tetanic count (PTC) 1-2.
干预措施: deep neuromuscular block (Drug)
high pressure + moderate block
Intra-abdominal pressure will be set to 12-15 mmHg during the surgery. Moderate neuromuscular block will be induced by rocuronium bolus 0.6 mg/kg, maintained by a continuous infusion of rocuronium (0.3mg/kg/h), and titrated towards train-of-four (TOF) twitch 1-2.
干预措施: high pressure (Procedure)
high pressure + moderate block
Intra-abdominal pressure will be set to 12-15 mmHg during the surgery. Moderate neuromuscular block will be induced by rocuronium bolus 0.6 mg/kg, maintained by a continuous infusion of rocuronium (0.3mg/kg/h), and titrated towards train-of-four (TOF) twitch 1-2.
干预措施: moderate neuromuscular block (Drug)
low pressure + deep block
Intra-abdominal pressure will be set to 7-10 mmHg during the surgery. Deep neuromuscular block will be induced by rocuronium bolus 1 mg/kg, maintained by a continuous infusion of rocuronium (0.6mg/kg/h), and titrated towards PTC 1-2.
干预措施: deep neuromuscular block (Drug)
low pressure + deep block
Intra-abdominal pressure will be set to 7-10 mmHg during the surgery. Deep neuromuscular block will be induced by rocuronium bolus 1 mg/kg, maintained by a continuous infusion of rocuronium (0.6mg/kg/h), and titrated towards PTC 1-2.
干预措施: low pressure (Procedure)
low pressure + moderate block
Intra-abdominal pressure will be set to 7-10 mmHg. Moderate neuromuscular block will be induced by rocuronium bolus 0.6 mg/kg, maintained by a continuous infusion of rocuronium (0.3mg/kg/h), and titrated towards TOF twitch 1-2.
干预措施: deep neuromuscular block (Drug)
low pressure + moderate block
Intra-abdominal pressure will be set to 7-10 mmHg. Moderate neuromuscular block will be induced by rocuronium bolus 0.6 mg/kg, maintained by a continuous infusion of rocuronium (0.3mg/kg/h), and titrated towards TOF twitch 1-2.
干预措施: moderate neuromuscular block (Drug)
结局指标
主要结局
Serum cystatin C (CysC) level
时间窗: Postoperative 24 hours
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
次要结局
- Serum creatine level(Postoperative 24 hours)
- The volume of intraoperative urine output(At the end of the surgery)
- The presence of isomorphic or dysmorphic erythrocyte in urinary sediment(Postoperative day 1)
- Duration of surgery(Intraoperative)
- Leiden-surgical rating scale(The moment when trocars are introduced into pelvic cavity, and then every 15 minutes till the end of surgery.)
- The number of bucking and body movement during the surgery(Intraoperative)
- Renal tissue oxygen saturation(Intraoperative)
研究者
Huang YuGuang
Dean of the Department of Anesthesiology
Peking Union Medical College Hospital