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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
648
High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.
Deep neuromuscular block is defined as PTC 1-2.
Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg.
Moderate neuromuscular block is defined as TOF twitch 1-2.
Serum cystatin C (CysC) level
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
Time frame: 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).
Time frame: 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).
Time frame: Postoperative 24 hours
Serum creatine level
Creatine is also an indicator for kidney injury
Time frame: 30 minutes before pneumoperitoneum insufflation
Serum creatine level
Creatine is also an indicator for kidney injury
Time frame: 30 minutes after pneumoperitoneum deflatation
Serum creatine level
Creatine is also an indicator for kidney injury
Time frame: 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.
Time frame: 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.
Time frame: Postoperative day 1
Duration of surgery
Duration of surgery is an indicator for procedure difficulty
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative
Renal tissue oxygen saturation
Renal oxygen saturation is an indicator for renal tissue oxygenation.
Time frame: Intraoperative
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