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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high pressure + deep block | Experimental | 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. |
|
| high pressure + moderate block | Experimental | 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. |
|
| low pressure + deep block | Experimental | 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. |
|
| low pressure + moderate block | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high pressure | Procedure | High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yahong Gong, M.D. | Contact | 86-13611273163 | yh2087@163.com | |
| Xiaohan Xu, M.D. | Contact | 86-15210560817 | smartannie@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuguang Huang, M.D. | Peking Union Medical College Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32600358 | Derived | 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. |
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The patients, surgeons and the ones who collect data will be masked.
| deep neuromuscular block | Drug | Deep neuromuscular block is defined as PTC 1-2. |
|
| low pressure | Procedure | Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg. |
|
| moderate neuromuscular block | Drug | Moderate neuromuscular block is defined as TOF twitch 1-2. |
|
| 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 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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