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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Acute Kidney Injury; Diabetes Mellitus; Laparoscopic Surgical Procedure; Neuromuscular Blockade

Treatments: Procedure: low pressure; Drug: deep neuromuscular block; Drug: moderate neuromuscular block; Procedure: high pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04259112

PUMCH-ml

Details and patient eligibility

About

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.

Full 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.

Enrollment: 648 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-70;
2. American Society of Anesthesiologist physical status (ASA) II-Ⅲ;
3. Diagnosed of diabetes;
4. Undergoing elective laparoscopic pelvic tumor resection under general anesthesia;
5. Estimated duration of operation >2h;

Exclusion criteria

1. Not willing to participate in the study or not able to sign the informed consent；
2. Diagnosed of other kidney diseases except diabetic nephropathy;
3. 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;
4. Severe liver, lung or heart dysfunction;
5. Known or suspect neuromuscular disease;
6. Use of drugs that may affect neuromuscular block monitoring;
7. Severe diabetic neuropathy or other peripheral neuropathy；
8. Known or suspect allergy to general anesthetics；
9. Family history of malignant hyperthermia；
10. Previous history of pelvic surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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648 participants in 4 patient groups

high pressure + deep block

Experimental group

Description:

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.

Treatment:

Procedure: high pressure

Drug: deep neuromuscular block

high pressure + moderate block

Experimental group

Description:

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.

Treatment:

Drug: moderate neuromuscular block

Procedure: high pressure

low pressure + deep block

Experimental group

Description:

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.

Treatment:

Procedure: low pressure

Drug: deep neuromuscular block

low pressure + moderate block

Experimental group

Description:

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.

Treatment:

Drug: moderate neuromuscular block

Drug: deep neuromuscular block