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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; Acute Kidney Injury; Neuromuscular Blockade; Laparoscopic Surgical Procedure
• Intervention / Treatment: Procedure: high pressure; Drug: deep neuromuscular block; Drug: moderate neuromuscular block; Procedure: low pressure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 648
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaohan Xu, M.D.; Phone Number: 86-15210560817; Email: smartannie@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high pressure + deep block; 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.	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.
Experimental: high pressure + moderate block; 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.	Procedure: high pressure; High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.; Drug: moderate neuromuscular block; Moderate neuromuscular block is defined as TOF twitch 1-2.
Experimental: low pressure + deep block; 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.	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.
Experimental: low pressure + moderate block; 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.	Drug: deep neuromuscular block; Deep neuromuscular block is defined as PTC 1-2.; Drug: moderate neuromuscular block; Moderate neuromuscular block is defined as TOF twitch 1-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum cystatin C (CysC) level	CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).	30 minutes before pneumoperitoneum insufflation
Serum cystatin C (CysC) level	CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).	30 minutes after pneumoperitoneum deflatation
Serum cystatin C (CysC) level	CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatine level	Creatine is also an indicator for kidney injury	30 minutes before pneumoperitoneum insufflation
Serum creatine level	Creatine is also an indicator for kidney injury	30 minutes after pneumoperitoneum deflatation
Serum creatine level	Creatine is also an indicator for kidney injury	Postoperative 24 hours
The volume of intraoperative urine output	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.	At the end of the surgery
The presence of isomorphic or dysmorphic erythrocyte in urinary sediment	Erythrocyte in urinary sediment is also an indicator of renal injury.	Postoperative day 1
Duration of surgery	Duration of surgery is an indicator for procedure difficulty	Intraoperative
Leiden-surgical rating scale	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.
The number of bucking and body movement during the surgery	The occurrence of bucking or body movement is an indicator for the sufficiency of muscle relaxant.	Intraoperative
Renal tissue oxygen saturation	Renal oxygen saturation is an indicator for renal tissue oxygenation.	Intraoperative

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yuguang Huang, M.D., Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 3, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Peritoneal Diseases; Endocrine System Diseases; Renal Insufficiency; Pneumoperitoneum; Diabetes Mellitus; Acute Kidney Injury
• Other Study ID Numbers: PUMCH-ml

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No