About this trial
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).
Eligibility criteria
Qualifiers
Men and women
Patient aged at least 18 years
Signed informed consent
American Society of Anesthesiologists (ASA) Class 1 to 3
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Titrated Opioid Sparing Anesthesia
- opioid free anesthesia