Clinical Trial

Endothelial Dysfunction and Nitric Oxyde During Laparoscopic Surgery

Study acronym: ED-NOanesth
Completed
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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.
Trial Details
NCT Number NCT07638124
Lead Sponsor Alexander Averyanov
Collaborators: I.M. Sechenov First Moscow State Medical University
Conditions Laparoscopic Abdominal Surgeries
Enrollment 40 participants
Start Date 2024-11-19
Primary Completion 2026-04-24 (estimated)
Study Completion 2026-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-10