Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthesia During Total Hip Arthroplasty
Sponsor: Pole Sante Oreliance, Polyclinique des Longues Allees
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-09-15
Completion Date
2027-10-01
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
Titrated Opioid Sparing Anesthesia
Opioid-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
anesthesia performed without opioid administration
Locations (1)
Pole Sante Oreliance, Polyclinique des Longues Allees
Saran, France