NCT05893030 Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk
| NCT ID | NCT05893030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Sedation and Analgesia Monitoring |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,132 participants |
| Start Date | 2023-10-12 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,132 participants in total. It began in 2023-10-12 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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; \> 0.25 mg/kg or or intravenous electric syringe * lidocaine or dexmedetomidine by continuous infusion; * refusal to participate in the study; * patient under guardianship, conservatorship, or unable to understand the study.
Contact & Investigator
David CHARIER, MD, PhD
PRINCIPAL INVESTIGATOR
CHU DE SAINT-ETIENNE
Frequently Asked Questions
Who can join the NCT05893030 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Sedation and Analgesia Monitoring. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05893030 currently recruiting?
Yes, NCT05893030 is actively recruiting participants. Contact the research team at david.charier@chu-st-etienne.fr for enrollment information.
Where is the NCT05893030 trial being conducted?
This trial is being conducted at Amiens, France, Amiens, France, Besançon, France, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT05893030 clinical trial?
NCT05893030 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is David CHARIER, MD, PhD at CHU DE SAINT-ETIENNE. The trial plans to enroll 1,132 participants.