Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthesia During Total Hip Arthroplasty

Starting soon · Not applicable

Conditions studied: Total Hip Arthroplasty (THA)

In brief

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).

Key facts

Study ID

NCT07747142

Run by

Pole Sante Oreliance, Polyclinique des Longues Allees

People needed

140

Starts

2026-09-15

Expected to finish

2027-10-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pole Sante Oreliance, Polyclinique des Longues Allees — Saran, France

Full record on ClinicalTrials.gov

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