Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery
Overview
- Phase
- Not Applicable
- Intervention
- high pressure
- Conditions
- Diabetes Mellitus
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 648
- Primary Endpoint
- Serum cystatin C (CysC) level
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Huang YuGuang
Dean of the Department of Anesthesiology
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: high pressure
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.
Intervention: deep neuromuscular block
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.
Intervention: high pressure
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.
Intervention: moderate neuromuscular block
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.
Intervention: deep neuromuscular block
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.
Intervention: low pressure
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.
Intervention: deep neuromuscular block
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.
Intervention: moderate neuromuscular block
Outcomes
Primary Outcomes
Serum cystatin C (CysC) level
Time Frame: Postoperative 24 hours
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
Secondary Outcomes
- 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)