Overview

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

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Peking Union Medical College Hospital

Criteria

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.