Clinical trial NCT06116383: Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery
Official title: Evaluation of Renal Perfusion With NIRS in Adult Patients Undergoing Laparoscopic Cholecystectomy.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pneumoperitoneum
Renal Injury
Keywords: laparoscopy
NIRS
N-GAL
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who undergoing elective laparoscopic cholecystectomi surgery

Brief summary: The investigators aimed to show the renal damage caused by increased intra-abdominal pressure in laparoscopic surgeries and to investigate whether its reflection on NIRS would be clinically effective.The main question it aims to answer are:

Does pneumoperitoneum cause renal damage?

NRS monitoring will be performed in patients undergoing laparoscopic surgery. Preoperative and postoperative blood tests will be performed at certain hours. N-GAL, urea and creatinine values will be recorded.

Detailed description: Renal NIRS monitoring will be performed in patients undergoing laparoscopic cholecystectomy surgery. Age, gender, BMI, ASA scores, hemogblin/hematocrit values, intraoperative hemodynamic parameters, NIRS values, N-GAL (preoperative, 2nd hour and 24th hour), urea/creatinine (preoperative, postoperative 24th hour) values of the patients will be recorded. .

Before the general anesthesia is performed, the renal tissues of the patients will be visualized by ultrasound, the skin-renal cortex distances will be measured, and suitable patients will be included in the study. Basal rSO2 values will be recorded by placing NIRS probes under the 10-11. intercostal space in the bilateral posterior lateral flank region.

Eligibility criteria: Inclusion Criteria:

* Patients who undergoing elective laparoscopic cholecystectomi surgery lasting longer than 60 minutes
* BMI:18-25
* skin-renal cortex distance measured less than 4 cm on ultrasound
* ASA I-III

Exclusion Criteria:

* patient who did not give consent
* patient who had renal operation before,
* infection, abscess, catheter in the perirenal region
* hemodynamically unstable patients,
* patients with renal pathology and abnormal kidney function tests,
* emergency cases

Primary outcomes:
measure: Evaluation of renal damage caused by pneumoperitoneum with N-GAL by blood test
timeFrame: During laparoscopic cholecystectomy operation and within 24 hours postoperative
measure: Evaluation of renal damage caused by pneumoperitoneum with urea/creatinin by blood test
timeFrame: During laparoscopic cholecystectomy operation and within 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: Savaş Altınsoy, MD
role: STUDY_CHAIR
References:
citation: Caliskan E, Sanal Bas S, Onay M, Kilic Y, Kayhan Erdogan G, Tokar B. Evaluation of renal oxygenization in laparoscopic pediatric surgery by near infrared spectroscopy. Pediatr Surg Int. 2020 Sep;36(9):1077-1086. doi: 10.1007/s00383-020-04709-w. Epub 2020 Jul 10.