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).
Men and women
Patient aged at least 18 years
Signed informed consent
American Society of Anesthesiologists (ASA) Class 1 to 3
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)
Parallel
Titrated Opioid Sparing Anesthesia
Procedure/SurgeryOpioid-sparing anesthesia using the CARDEAN® index, which enables specific monitoring of nociception during general anesthesia. By adjusting sufentanil administration in real time based on variations in surgical painful stimuli, the CARDEAN® index enables titrated opioid-sparing anesthesia (titrated OSA).
opioid free anesthesia
Procedure/Surgeryanesthesia performed without opioid administration
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)
Stability of heart rate (HR) and mean arterial pressure (MAP)
* Number of heart rate episodes deviating by ±20% for more than 15 seconds from the baseline heart rate, relative to the duration of the procedure * Number of mean arterial pressure (MAP) values deviating by ±20% from the baseline MAP, relative to the duration of the procedure * Number of boluses and total doses of cardiotropic and vasoactive drugs: atropine, norepinephrine, nicardipine
Speed of emergence from anesthesia in the post-anesthesia care unit (PACU)
Postoperative pain control
Maximum pain score on a 0-10 numerical rating scale (NRS max) in the PACU
Adverse effects of postoperative opioids
Number of hypoxia episodes in the PACU (hypoxia defined as SpO2 ≤ 94% on room air)
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