Here is the design of a 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

Included conditions:
- Diabetes Mellitus
- Acute Kidney Injury
- Laparoscopic Surgical Procedure
- Neuromuscular Blockade

Study Armgroups:
- {'label': 'high pressure + deep block', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Procedure: high pressure', 'Drug: deep neuromuscular block']}
- {'label': 'high pressure + moderate block', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Procedure: high pressure', 'Drug: moderate neuromuscular block']}
- {'label': 'low pressure + deep block', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Drug: deep neuromuscular block', 'Procedure: low pressure']}
- {'label': 'low pressure + moderate block', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Drug: deep neuromuscular block', 'Drug: moderate neuromuscular block']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'high pressure', 'description': 'High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.', 'armGroupLabels': ['high pressure + deep block', 'high pressure + moderate block']}
- {'type': 'DRUG', 'name': 'deep neuromuscular block', 'description': 'Deep neuromuscular block is defined as PTC 1-2.', 'armGroupLabels': ['high pressure + deep block', 'low pressure + deep block', 'low pressure + moderate block']}
- {'type': 'PROCEDURE', 'name': 'low pressure', 'description': 'Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg.', 'armGroupLabels': ['low pressure + deep block']}
- {'type': 'DRUG', 'name': 'moderate neuromuscular block', 'description': 'Moderate neuromuscular block is defined as TOF twitch 1-2.', 'armGroupLabels': ['high pressure + moderate block', 'low pressure + moderate block']}

Primary Outcomes:
- {'measure': 'Serum cystatin C (CysC) level', 'description': 'CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).', 'timeFrame': '30 minutes before pneumoperitoneum insufflation'}
- {'measure': 'Serum cystatin C (CysC) level', 'description': 'CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).', 'timeFrame': '30 minutes after pneumoperitoneum deflatation'}
- {'measure': 'Serum cystatin C (CysC) level', 'description': 'CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).', 'timeFrame': 'Postoperative 24 hours'}

Please estimate the sample size based on the assumption: 
The power analysis was conducted to achieve 90% power at a 5% significance level. A 10% dropout rate was also considered. Statistical analysis will use a two-sided P value < 0.05 as significant.
Sample size calculation and statistical analysis
        A previous study [15] reported that the standard deviation of serum CysC level after laparoscopic procedures is 0.738âÂ±â0.186âmg/dl. For a CysC difference of 0.05âmg/dl to be considered clinically significant, a power analysis program (G* power 3.1) calculated that a total sample size of 582 patients is needed to achieve 90% power at the 5% significance level. Considering a 10% dropout rate, a total of 648 patients (162 per group) is necessary. Approximately 5000 patients are scheduled for elective major pelvic surgery in PUMCH every year, and approximately 15% of them have diabetes; thus, one year is estimated as necessary to achieve adequate participant enrollment.
        We will first compare the two SPP groups with the two LPP groups and then compare the two deep-NMB groups with the two moderate-NMB groups. Finally, all four groups will be compared.
        The baseline characteristics and intraoperative factors of the enrolled patients will be evaluated using descriptive analysis. Continuous variables will be summarized as the meanââÂ±ââstandard deviation (SD) or median (interquartile range, IQR) as appropriate, whereas categorial variables will be summarized as the number (percentage). The baseline characteristics will be compared between groups using the standardized difference, and a standardized differenceâ<â0.2 will be considered an acceptable balance between groups. Unbalanced variables at baseline will be included in the ANOVA or mixed-effects model to adjust for the potential confounding effect.
        Considering the multiple measures of CysC, Cr, surgical condition rating scale, and renal tissue oxygen saturation at different time points, the effect of intervention in the whole timeframe will be analyzed by a mixed-effects model. Other continuous variables will be compared by two-sided independent Studentâs t tests or the MannâWhitney U test, as appropriate. Categorical variables will be analyzed by a Chi-square test or Fisherâs exact test, as appropriate. The Bonferroni method will be used to correct the potential increase in the probability of a type I error when analyzing the differences between the four groups.
        We will also investigate the interaction between pneumoperitoneum pressure and NMB on postoperative renal function. The difference in serum Cysc levels at T2 between the Sâ+âD and Lâ+âD groups will be compared with that between the Sâ+âM and Lâ+âM groups. If there is no significant difference, we will assume there is no interaction.
        We will perform statistical analysis using R (version 3.4.4). Two-sided P values <â0.05 will be considered significant.
        Based on ITT principle, we will analyze all the post-randomization cases, including the ones with missing data. The missing data of the repeatedly measured outcomes will be imputed using the âlast observation carried forwardâ method, while the missing data of other outcomes will be imputed by baseline data. Sensitivity analysis will be performed to assess the bias that may be introduced due to nonadherence to protocol or missing data.