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COMPLETED
NCT07638124
NA

Endothelial Dysfunction and Nitric Oxyde During Laparoscopic Surgery

Sponsor: Alexander Averyanov

View on ClinicalTrials.gov

Summary

This single-centre, pilot, prospective, randomized, open-label clinical trial evaluated the effect of intraoperative inhaled nitric oxide (iNO) on endothelial function, intestinal and renal injury biomarkers, and early clinical outcomes in high-risk cardiovascular patients undergoing prolonged laparoscopic abdominal surgery (\>120 minutes). Forty adults with cardiovascular disease and an RCRI ≥2 were randomized 1:1 to receive either iNO at 40 ppm via the ventilator circuit from post-intubation to the end of surgery or standard anaesthetic management without iNO. The primary endpoint was the 12-hour postoperative change in endothelial dysfunction markers (total nitric oxide, endothelin-1, von Willebrand factor); secondary endpoints included markers of intestinal and renal injury (I-FABP, LBP, creatinine), tissue expression of VCAM-1 and iNOS, postoperative complications, gastrointestinal recovery, and hospital length of stay.

Official title: Endothelial Dysfunction and Inhaled Nitric Oxyde During Laparoscopic Surgery: : a Pilot Prospective Randomized Study

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-11-19

Completion Date

2026-05-15

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

PROCEDURE

Inhaled nitric oxide at 40 ppm administered via the inspiratory limb of the anaesthesia ventilator circuit

Patients receive inhaled nitric oxide at 40 ppm administered via the inspiratory limb of the anaesthesia ventilator circuit. iNO is initiated immediately after tracheal intubation and continued until the end of surgery; the median iNO exposure in the pilot cohort was approximately 168 minutes. Inspired NO and NO₂ concentrations are continuously monitored according to device instructions.

Locations (1)

First Moscow State Medical University named after I.M. Sechenov (Sechenov University)

Moscow, Russia