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Endothelial Dysfunction and Nitric Oxyde During Laparoscopic Surgery

NCT07638124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

  • Laparoscopic Abdominal Surgeries

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.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Alexander Averyanov

    lead OTHER_GOV

Principal Investigators

  • Irina A Mandel, MD, PhD · First Moscow State Medical University named after I.M. Sechenov (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-04-24
Completion
2026-05-15

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638124 on ClinicalTrials.gov