Diabetes Mellitus Clinical Trial
Official title:
Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Peking Union Medical College Hospital |
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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