Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery

Pneumoperitoneum Clinical Trial

Official title:

Evaluation of Renal Perfusion With NIRS in Adult Patients Undergoing Laparoscopic Cholecystectomy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116383
• Other study ID #: NIRS
• Status: Not yet recruiting
• Start date: November 10, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Savas Altinsoy, MD
• Phone: 0905332257104
• Email: savasaltinsoy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumoperitoneum
• Renal Injury

Intervention

Device:
• NIRS
Renal perfusion will be evaluated with NIRS

Locations

Country	Name	City	State
Turkey	Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of renal damage caused by pneumoperitoneum with N-GAL by blood test	Taking a blood test to evaluation N-GAL	During laparoscopic cholecystectomy operation and within 24 hours postoperative
Primary	Evaluation of renal damage caused by pneumoperitoneum with urea/creatinin by blood test	Taking a blood test to evaluation urea/creatinine values	During laparoscopic cholecystectomy operation and within 24 hours postoperative