Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hyp… (NCT05893030) | Clinical Trial Compass
RecruitingNot Applicable
Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk
France1,132 participantsStarted 2023-10-12
Plain-language summary
Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Intraoperative hypotension is partly related to anesthesia, and mainly to the combined, dose-dependent, synergistic effect of hypnotics and opioids. Monitoring sedation and monitoring analgesia reduce intraoperative consumption of each anesthetic agent. To date, the beneficial effect of combined sedation and analgesia monitoring on the reduction of intraoperative hypotension has only been found in one study, involving major abdominal surgery. Up to now, no study has been designed to demonstrate the benefit of monitoring the two components of anesthesia on postoperative organ dysfunction and mortality.
The study propose to evaluate the relevance of a combined optimization of hypnotic and opioid agents on the most frequently encountered dysfunctions related to intraoperative hypotension.
Who can participate
Age range
75 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:
* patients affiliated to the French Social Security;
* informed and signed consent to participating in the study;
* planned postoperative hospitalization \> 48 hours;
* patients over 75 years of age with at least one of the following postoperative risk factors:
* ischemic coronary disease;
* history of compensated or prior heart failure;
* stroke;
* significant arrhythmias: fibrillation or auricular flutter with ventricular response \> 100/minute, multiform QRS complex) or cardiac conduction abnormalities (trifascicular block, auriculoventricular block of the second or third degree);
* peripheral vascular disease;
* chronic obstructive pulmonary disease;
* chronic respiratory failure;
* renal insufficiency, defined by a creatinine \> 175 µmol.l-1 (2 mg.dl-1);
* insulin therapy for diabetes;
* active cancer;
* chronic alcohol abuse;
* dementia.
* elective or emergency high-risk surgery under general anesthesia with a combination of hypnotic and opioid, and intubation or placement of a supraglottic airway control device
Non inclusion criteria:
* Patients who meet one or more of the preoperative following criteria will not be included:
* acute heart failure or acute myocardial infarction;
* complete arrhythmia due to atrial fibrillation;
* acute respiratory failure or pneumonia;
* septic shock;
* acute stroke;
* cardiac surgery;
* open chest surgery;
* opioid free anesthesia;
* intraoperative ketamine at a dose \> 0.25 mg.kg-1; \> …
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
death
Timeframe: Day 30
2
Postoperative acute kidney injury (PO-AKI)
Timeframe: Day 30
3
cardiovascular complication
Timeframe: Day 30
4
neurological complication
Timeframe: Day 30
5
Post-operative delirium (POD)
Timeframe: Day 30
Trial details
NCT IDNCT05893030
SponsorCentre Hospitalier Universitaire de Saint Etienne