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

Diabetes Mellitus Clinical Trial

Official title:

Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04259112
• Other study ID #: PUMCH-ml
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2020
• Source: Peking Union Medical College Hospital
• Contact: Yahong Gong, M.D.
• Phone: 86-13611273163
• Email: yh2087[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 648
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Aged 18-70;

2. American Society of Anesthesiologist physical status (ASA) II-?;

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Serum creatine level	Creatine is also an indicator for kidney injury	30 minutes before pneumoperitoneum insufflation
Secondary	Serum creatine level	Creatine is also an indicator for kidney injury	30 minutes after pneumoperitoneum deflatation
Secondary	Serum creatine level	Creatine is also an indicator for kidney injury	Postoperative 24 hours
Secondary	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
Secondary	The presence of isomorphic or dysmorphic erythrocyte in urinary sediment	Erythrocyte in urinary sediment is also an indicator of renal injury.	Postoperative day 1
Secondary	Duration of surgery	Duration of surgery is an indicator for procedure difficulty	Intraoperative
Secondary	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.
Secondary	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
Secondary	Renal tissue oxygen saturation	Renal oxygen saturation is an indicator for renal tissue oxygenation.	Intraoperative