Endothelial Dysfunction and Nitric Oxyde During Laparoscopic Surgery (NCT07638124) | Clinical Trial Compass
CompletedNot Applicable
Endothelial Dysfunction and Nitric Oxyde During Laparoscopic Surgery
Russia40 participantsStarted 2024-11-19
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years.
* Documented cardiovascular disease, including at least one of the following: coronary artery disease, stable angina pectoris (II-III functional class), chronic heart failure (NYHA I-III), prior myocardial infarction, or cerebrovascular disease.
* Revised Cardiac Risk Index (RCRI) ≥2 (moderate/high perioperative risk).
* Scheduled for elective laparoscopic abdominal surgery (e.g., colorectal, gastric, hepatic resections) with expected duration \>120 minutes.
* Ability to provide written informed consent.
Exclusion Criteria:
* Pregnancy or lactation.
* Baseline methemoglobin level \>3%.
* Known hypersensitivity or contraindication to inhaled NO.
* Chronic intake of NO donors (e.g., nitroglycerin, isosorbide) or drugs known to increase methemoglobin (e.g., lidocaine, prilocaine, benzocaine).
* Severe neutropenia (neutrophils \<500/mm³) or severe thrombocytopenia (platelets \<30,000/mm³).
* Haemoglobin \<7 g/dl.
* Severe renal failure (estimated GFR \<30 ml/min/1.73 m²).
* Poorly controlled diabetes mellitus (HbA1c \>9% or frequent hypoglycaemia).
* Significant electrolyte disorders (K⁺ \<3.0 or \>5.5 mmol/l; Na⁺ \<125 or \>155 mmol/l).
* Any acute exacerbation of chronic disease on the day of surgery.
* Need to convert to open laparotomy during surgery (exclusion from analysis).
* Requirement for extracorporeal life support or other advanced organ support not compatible with protocol procedures.
* Participation in another interventional c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Markers of endothelial dysfunction
Timeframe: from baseline (1 hour pre-operatively) to 12 hours postoperatively
2
Markers of endothelial dysfunction
Timeframe: from baseline (1 hour pre-operatively) to 12 hours postoperatively
3
Markers of endothelial dysfunction
Timeframe: from baseline (1 hour pre-operatively) to 12 hours postoperatively