Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06116383

Collaborator

(none)

Enrollment

Location

5.7

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumoperitoneum Renal Injury	Device: NIRS

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 Design

Study Type:

Observational

Anticipated Enrollment :

58 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 10, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients undergoing laparoscopic cholecystectomy. 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. .	Device: NIRS Renal perfusion will be evaluated with NIRS

Arm

Intervention/Treatment

Patients undergoing laparoscopic cholecystectomy.

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. .

Device: NIRS

Renal perfusion will be evaluated with NIRS

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital	Ankara		Turkey	06450

Sponsors and Collaborators

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

Study Chair: Savaş Altınsoy, MD, Ankara Etlik City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Savas Altinsoy, Associate Professor MD, Diskapi Yildirim Beyazit Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT06116383

Other Study ID Numbers:

NIRS

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Savas Altinsoy, Associate Professor MD, Diskapi Yildirim Beyazit Education and Research Hospital

laparoscopy

NIRS

N-GAL

Additional relevant MeSH terms:

Pneumoperitoneum

Study Results

No Results Posted as of Nov 7, 2023