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临床试验/NCT03219398
NCT03219398已完成不适用

Comparison Effect Between Lower Pressure and Standard Pressure Pneumoperitoneum on Sign of Acute Systemic Inflammation, Endothelial Injury, and Acute Kidney Injury: A Randomized Clinical Trial in Living Donor Laparoscopic Nephrectomy

Indonesia University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Changes in KIM-1 level from baseline

研究概览

简要总结

This study aimed to evaluate the increase of intraabdominal pressure 12- 14 mmHg caused by pneumoperitoneum resulted from carbon dioxide (CO2) insufflation induce glycocalyx endothelial injury that cause kidney tubular injury on live donor patient that undergo laparoscopic nephrectomy surgery, and decreasing the intraabdominal pressure to 8-10 mmHg during surgery is expected to reduce the injury.

详细描述

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula (18-20G) with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG), ICON® monitor, hemodynamic monitor and pulse-oxymetry were set on the subjects in the operation room. Premedication with 2 mg IV midazolam and 1 mcg/kg IV fentanyl as premedication. General anesthesia induction was done by fentanyl 4 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0,5 mg/kg. Maintenance was done by sevoflurane 1 minimum alveolar concentration (MAC), fentanyl and rocuronium with bupivacaine bolus 6ml every 90 minutes. Surgery starts with patient in lumbotomy position laterally, CO2 gas insufflated during the installment of laparoscopy probe until it reaches 10- 12 mmHg pressure. Laparoscopy targeted the pneumoperitoneum pressure until 8- 10 mmHg or 12- 14 mmHg depends on subject randomization. Surgery duration, blood pressure, heart rate, respiratory rate, oxygen saturation (SpO2) were recorded. During surgery, blood sample for interleukin (IL)-6, Syndecan-1, sVGEF-R2, Occludin and KIM-1 urine were taken before the anesthesia induction as the baseline; 2 hours of gas insufflation intraoperatively; and 2 hours after gas desufflation. The measurement of renal artery and kidney lobe artery that undergo nephrectomy, will be measured by convex probe 3.5-5 megahertz (MHz) ultrasonography (USG) Logic 7-GE or Sonosite. The measurement of RI was done on the left kidney at the time: before the anesthesia induction as the baseline; 2 hours of gas insufflation intraoperatively; and 2 hours after gas desufflation on the remaining right kidney. All patients received bilateral Quadratus Lumborum (QL) block using bupivacaine 0.25% before extubation. Patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation. Data was analyzed using SPSS (Statistical Package for Social Scientist), for parametric unpaired data is using unpaired T-test or One way ANOVA test, ffor unpaired non parametric data using Mann Whitney or Kruskal-Wallis. Non Parametric continuous data using Wilcoxon's signed rank test or Friedman Test. Categorical data using Chi-square. For numerical data more than 1 measurement will be analysed using Comparative General Linear Model. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 18-60 years old undergoing laparoscopic surgery, with American Society of Anesthesiologist (ASA) 1, body mass index 18-
  • Patients who agreed to participate in this study and sign informed consent.

排除标准

  • Subjects in the outside criteria of American Society of Anesthesia 1, body mass index >25.

研究组 & 干预措施

8-10 mmHg

Active Comparator

Patients receive lower pneumoperitoneum pressure

干预措施: Pneumoperitoneum pressure (Procedure)

12-14 mmHg

Active Comparator

Patients receive higher pneumoperitoneum pressure

干预措施: Pneumoperitoneum pressure (Procedure)

结局指标

主要结局

Changes in KIM-1 level from baseline

时间窗: 24 hours

Measurement of Urinary KIM-1 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation

Changes in sVGEFR-2 level from baseline

时间窗: 24 hours

Measurement of plasma soluble VGEF-R2 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation

Changes in Syndecan-1 level from baseline

时间窗: 24 hours

Measurement of plasma Syndecan-1 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation

Changes in Interleukin-6 from baseline

时间窗: 24 hours

Measurement of plasma Interleukin-6 after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation

次要结局

  • Intraoperative fentanyl dosage(24 hours)
  • Changes in Renal Resistive Index from baseline(24 hours)
  • Changes in Occludin level from baseline(24 hours)
  • Renal biopsy tissue Syndecan-1(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dita Aditianingsih

Anesthesiologist Consultant, Principal Investigator

Indonesia University

研究点 (2)

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