CompletedNot Applicable

Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric

Turkey (Türkiye)66 participantsStarted 2024-03-20

Plain-language summary

To investigate the effects of non-invasive cerebral and peripheral NIRS monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral NIRS in paediatric patients. To determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur.

Who can participate

Age range

2 Years – 12 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: * Between 2-12 years of age, those who are planned to undergo pediatric surgery, orthopedic and urological surgery, and whose procedure time is 1 hour or more * ASA I-III risk group * Patients who agreed to be included in the study * Patients whose informed consent form is approved by their parents will be included in the study. Exclusion Criteria: * Patients who do not want to participate in the study * Patients with ASA score above III * ASA III patients with decompensated cardiac and pulmonary disease * Patients with neurological sequelae * Cases with an operation duration of less than 1 hour * Patients with contraindications to the use of any anesthetic drugs * Patients for whom low-flow anesthesia is contraindicated * Smoke and gas poisoning * Malignant Hyperthermia * Septic Shock * CO2 absorbent depletion * Insufficient oxygen monitoring * Laparoscopic surgeries * Patients who develop unexpected intra-operative surgical complications * Patients whose parents do not approve the informed consent form will not be included in the study.

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

Near infrared spectroscopy (NIRS)

Timeframe: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

Trial details

NCT IDNCT06320743

SponsorAnkara City Hospital Bilkent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Child, Only trials