NCT04259112

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 648 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Acute Kidney Injury
• Laparoscopic Surgical Procedure
• Neuromuscular Blockade

Interventions

Type	Name	Description
PROCEDURE	high pressure	High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.
DRUG	deep neuromuscular block	Deep neuromuscular block is defined as PTC 1-2.
PROCEDURE	low pressure	Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg.
DRUG	moderate neuromuscular block	Moderate neuromuscular block is defined as TOF twitch 1-2.

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2020-02-06
• Last updated: 2020-10-06