Effect of Pneumoperitoneum and Neuromuscular Block on Renal Function in Diabetes Patients

Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery

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.

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.

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.

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.

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.

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.

CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).

CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).

CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).

A urine tube will be inserted just before the surgery, so the urine can be drained into a bag. The volume of urine in the bag at the end of the surgery will be the volume of intraoperative urine output.

We will use Leiden surgical rating scale (Martini et al.) to assess surgical condition. It is a 5-point scale, the minimum and maximum values are 1 and 5, respectively. Higher score indicates better surgical condition.

The moment when trocars are introduced into pelvic cavity, and then every 15 minutes till the end of surgery.

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; 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.

Xu X, Gong Y, Zhang Y, Lang J, Huang Y. Effect of pneumoperitoneum pressure and the depth of neuromuscular block on renal function in patients with diabetes undergoing laparoscopic pelvic surgery: study protocol for a double-blinded 2 x 2 factorial randomized controlled trial. Trials. 2020 Jun 29;21(1):585. doi: 10.1186/s13063-020-04477-x.