Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthesia During Total Hip Arthroplasty | NCT07747142

NCT07747142

Overview

NCT ID: NCT07747142
Lead Sponsor: Pole Sante Oreliance, Polyclinique des Longues AlleesOTHER
Official Title: Comparaison Entre anesthésie Avec épargne Morphinique guidée Par l'Index CARDEAN® et anesthésie Sans Morphinique au Cours Des Arthroplasties Totales de Hanche : étude randomisée
Brief 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).

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Sep 15, 2026Estimated
Primary Completion Date: Oct 1, 2027Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 140Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Jean-Yves JY Martinez, DoctorContact
jyvesmartinez@yahoo.com

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