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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04259112
Other study ID # PUMCH-ml
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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