The Effect of Lower Intraabdominal Pressure on Syndecan-1, sVEGF-R2, Occludin, KIM-1, and IL-6 on Living Donor Laparoscopic Nephrectomy
Condition: Healthy
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Pneumoperitoneum pressure
Intervention type(s): Procedure
Intervention description(s): Subjects were set to 8- 10 mmHg pressure during laparoscopic surgery; Subjects were set to 12-14 mmHg pressure during laparoscopic surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Living donor laparoscopic nephrectomy; Pneumoperitoneum; Renal resistive index; Syndecan-1; soluble VEGF-R2; Occludin; KIM-1; Interleukin-6