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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPole Sante Oreliance, Polyclinique des Longues Allees

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

Treatment groups

140 Participants
are divided into 2 treatment groups