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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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).

Eligibility

Primary outcome measure(s)

• 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) — During the first 24 hours after the start of anesthesia

Trial sites (1)

Other trials for the same condition