Diabetes Mellitus, Acute Kidney Injury, Laparoscopic Surgical Procedure, Neuromuscular Blockade
Conditions
Brief 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.
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.
Interventions
PROCEDUREhigh pressure
High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.
Deep neuromuscular block is defined as PTC 1-2.
PROCEDURElow pressure
Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg.
Moderate neuromuscular block is defined as TOF twitch 1-2.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The patients, surgeons and the ones who collect data will be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum cystatin C (CysC) level | 30 minutes before pneumoperitoneum insufflation | CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The volume of intraoperative urine output | At the end of the surgery | 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. |
| The presence of isomorphic or dysmorphic erythrocyte in urinary sediment | Postoperative day 1 | Erythrocyte in urinary sediment is also an indicator of renal injury. |
| Duration of surgery | Intraoperative | Duration of surgery is an indicator for procedure difficulty |
| Serum creatine level | 30 minutes before pneumoperitoneum insufflation | Creatine is also an indicator for kidney injury |
| The number of bucking and body movement during the surgery | Intraoperative | The occurrence of bucking or body movement is an indicator for the sufficiency of muscle relaxant. |
| Renal tissue oxygen saturation | Intraoperative | Renal oxygen saturation is an indicator for renal tissue oxygenation. |
| Leiden-surgical rating scale | The moment when trocars are introduced into pelvic cavity, and then every 15 minutes till the end of surgery. | 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. |
Contacts
Primary ContactYahong Gong, M.D.
Backup ContactXiaohan Xu, M.D.
Outcome results
None listed