Clinical trial NCT04259112: Effect of Pneumoperitoneum and Neuromuscular Block on Renal Function in Diabetes Patients
Official title: Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Acute Kidney Injury
Laparoscopic Surgical Procedure
Neuromuscular Blockade
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Serum cystatin C (CysC) level
timeFrame: 30 minutes before pneumoperitoneum insufflation
measure: Serum cystatin C (CysC) level
timeFrame: 30 minutes after pneumoperitoneum deflatation
measure: Serum cystatin C (CysC) level
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Serum creatine level
timeFrame: 30 minutes before pneumoperitoneum insufflation
measure: Serum creatine level
timeFrame: 30 minutes after pneumoperitoneum deflatation
measure: Serum creatine level
timeFrame: Postoperative 24 hours
measure: The volume of intraoperative urine output
timeFrame: At the end of the surgery
measure: The presence of isomorphic or dysmorphic erythrocyte in urinary sediment
timeFrame: Postoperative day 1
measure: Duration of surgery
timeFrame: Intraoperative
measure: Leiden-surgical rating scale
timeFrame: The moment when trocars are introduced into pelvic cavity, and then every 15 minutes till the end of surgery.
measure: The number of bucking and body movement during the surgery
timeFrame: Intraoperative
measure: Renal tissue oxygen saturation
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuguang Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.