Effect of Pneumoperitoneum and Neuromuscular Block on Renal Function in Diabetes Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: high pressure + deep block 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. |
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.
|
| Experimental: high pressure + moderate block 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. |
Procedure: high pressure
High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.
Drug: moderate neuromuscular block
Moderate neuromuscular block is defined as TOF twitch 1-2.
|
| Experimental: low pressure + deep block 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. |
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.
|
| Experimental: low pressure + moderate block 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. |
Drug: deep neuromuscular block
Deep neuromuscular block is defined as PTC 1-2.
Drug: moderate neuromuscular block
Moderate neuromuscular block is defined as TOF twitch 1-2.
|
Outcome Measures
Primary Outcome Measures
- 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).
- Serum cystatin C (CysC) level [30 minutes after pneumoperitoneum deflatation]
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
- Serum cystatin C (CysC) level [Postoperative 24 hours]
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
Secondary Outcome Measures
- Serum creatine level [30 minutes before pneumoperitoneum insufflation]
Creatine is also an indicator for kidney injury
- Serum creatine level [30 minutes after pneumoperitoneum deflatation]
Creatine is also an indicator for kidney injury
- Serum creatine level [Postoperative 24 hours]
Creatine is also an indicator for kidney injury
- 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
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 18-70;
-
American Society of Anesthesiologist physical status (ASA) II-Ⅲ;
-
Diagnosed of diabetes;
-
Undergoing elective laparoscopic pelvic tumor resection under general anesthesia;
-
Estimated duration of operation >2h;
Exclusion criteria:
-
Not willing to participate in the study or not able to sign the informed consent；
-
Diagnosed of other kidney diseases except diabetic nephropathy;
-
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;
-
Severe liver, lung or heart dysfunction;
-
Known or suspect neuromuscular disease;
-
Use of drugs that may affect neuromuscular block monitoring;
-
Severe diabetic neuropathy or other peripheral neuropathy；
-
Known or suspect allergy to general anesthetics；
-
Family history of malignant hyperthermia；
-
Previous history of pelvic surgery.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Yuguang Huang, M.D., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PUMCH-ml