Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery

Not yet recruiting

• Conditions: Renal Injury; Pneumoperitoneum
• Interventions: Device: NIRS

• Registration Number: NCT06116383
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-10-30
• Status Verified: 2023-11
• Study First Posted: 2023-11-03
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07
• Study Start: 2023-11-10
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing laparoscopic cholecystectomy.	NIRS	Basal rSO2 values will be recorded by placing NIRS probes under the 10-11th intercostal space in the bilateral posterior lateral flank region. Age, gender, BMI, ASA scores, Hb/Htc 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. .

Primary Outcome Measures

Name	Time	Method
Evaluation of renal damage caused by pneumoperitoneum with N-GAL by blood test	During laparoscopic cholecystectomy operation and within 24 hours postoperative	Taking a blood test to evaluation N-GAL
Evaluation of renal damage caused by pneumoperitoneum with urea/creatinin by blood test	During laparoscopic cholecystectomy operation and within 24 hours postoperative	Taking a blood test to evaluation urea/creatinine values

Trial Locations

Locations (1)

Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital; 🇹🇷 Ankara, Turkey