Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthe… (NCT07747142) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthesia During Total Hip Arthroplasty
France140 participantsStarted 2026-09-15
Plain-language summary
The proposed study compares two anesthesia techniques; the hypothesis being tested is that titrating sufentanil based on the CARDEAN® index (titrated OSA) does not increase post-operative morphine consumption compared to opioid-free anesthesia (OFA). This CARDEAN®-guided titrated anesthesia approach could potentially allow for hospital discharge as early as 24 hours post-operatively and is compatible with ERAS protocols. The primary objective is to demonstrate that sufentanil administration guided by the CARDEAN® index (titrated OSA) does not increase postoperative morphine consumption compared to opioid-free anesthesia (OFA). This is a prospective, single-center, randomized, single-blind, non-inferiority study.
Two groups of 70 patients each (140 patients in total) are compared based on the type of intraoperative analgesia: titrated OSA (Arm 1) versus OFA (Arm 2).
Randomization will be performed at a 1:1 ratio and stratified by surgical approach (anterior or lateral approach).
Who can participate
Age range
18 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:
* Men and women
* Patient aged at least 18 years
* Signed informed consent
* American Society of Anesthesiologists (ASA) Class 1 to 3
* Scheduled total hip arthroplasty under general anesthesia (anterior or lateral approach) with local analgesic infiltration performed by the surgeon at the end of the procedure
* Affiliated with or a beneficiary of a social security scheme.
Exclusion Criteria:
* ASA Class 4 or 5
* Emergency hip surgery
* Indication for an anesthesia technique other than general anesthesia (patient preference, benefit-risk ratio, etc.)
* Permanent cardiac arrhythmia or permanent cardiac pacing (invalid CARDEAN® index)
* Resting bradycardia \< 50 bpm
* Second- or third-degree atrioventricular block
* Chronic opioid user
* Refusal of consent
* Patient unable to read, write, or understand French
* Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)
* Adult patient under guardianship, curatorship, or judicial protection
* Patient unable to personally provide consent as defined by Article L.1121-8 of the CSP, or an adult under legal protection
* Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP
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
Total dose of morphine required to maintain a pain score ≤ 3 on a numerical scale of 1 to 10 during the first 24 hours (dose expressed as oral morphine equivalent, OME)
Timeframe: During the first 24 hours after the start of anesthesia
Trial details
NCT IDNCT07747142
SponsorPole Sante Oreliance, Polyclinique des Longues Allees