The aim of this study is to investigate if it is feasible to use a protocol in which avoiding oxygen desaturation in the brain during general anaesthesia can reduce the risk of negative postoperative behavior changes in children.
We will recruit children from at least five centres around the world for this feasibility study. Brain oxygenation will be monitored with Near Red Infrascopy (NIRS) which is like a saturation monitor placed on the forehead of the child during anesthesia. The anesthesia is done as per routine, but we will ask the anesthesiologist to record what actions they took when there were signs of decreasing oxygen saturation in the brain. We will also ask the parents to fill in a questionnaire with 27 questions about changes in their child's behavior 7 days after the operation.
Who can participate
Age range
6 Months – 59 Months
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:
* Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.
Exclusion Criteria:
* age \< 6 months or ≥ 59 months
* procedures requiring \< 30 minutes of general anaesthesia
* imaging procedures
* procedures involving neurosurgery, oncology or burns
* procedures involving significant pain lasting for more than 1 week on average (e.g. tonsillectomies, major orthopaedic surgery)
* other procedures that limit access to the forehead
* children that are on supplemental oxygen, are sedated or intubated at the time of inclusion
* children with severe developmental delay
* procedures with planned postoperative intensive care or hospital stay \> 3 days
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
the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist
Timeframe: From the beginning of the anesthesia until 30 days postoperatively