The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cogn… (NCT03107260) | Clinical Trial Compass
CompletedNot Applicable
The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.
France181 participantsStarted 2016-01-15
Plain-language summary
There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies.
Age is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.
Who can participate
Age range
65 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 ≥ 65 years
* Non-cardiac, thoracic and vascular emergency surgery
* Surgery under general anesthesia
* ASA I, II or III
* Simple information without consent
* Patient affiliated to social security
Exclusion Criteria:
* Inability to understand
* Patient under tutelage, or curatorship or deprived of public right
* ASA IV
* History of severe dementia MMSE \<20
* Personal or familial history of malignant hyperthermia
* History of allergy or hypersensitivity to anesthetic products used
* Contra-indication to Cisatracurium®: myasthenia gravis
* Contra-indication to Sevoflurane®
* Contra-indication to local anesthetics
* Indication of use of a Ketamine®-type hypnotic (modification of the BIS)
* Indication of use of nitrous oxide
* History of cranial trauma
* Neuromuscular pathology
* Spinal anesthesia
* Cardiac, thoracic or vascular surgery
* Surgery not performed in emergency
* Neurochirugia in the context of cranial trauma
* Any surgery that does not allow the use of the NIRS (impossibility of positioning of the electrodes by the location of the surgical field).
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.