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NCT Number: NCT07747142

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

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).

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Key information

Conditions

Total Hip Arthroplasty (THA)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women
  • Patient aged at least 18 years
  • Signed informed consent
  • American Society of Anesthesiologists (ASA) Class 1 to 3
  • Scheduled total hip arthroplasty under general anesthesia (anterior or lateral approach) with local analgesic infiltration performed by the surgeon at the end of the procedure
  • Affiliated with or a beneficiary of a social security scheme.

Exclusion criteria

  • 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)
  • Resting bradycardia < 50 bpm
  • Second- or third-degree atrioventricular block
  • Chronic opioid user
  • Refusal of consent
  • Patient unable to read, write, or understand French
  • Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)
  • Adult patient under guardianship, curatorship, or judicial protection
  • Patient unable to personally provide consent as defined by Article L.1121-8 of the CSP, or an adult under legal protection
  • Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP

Treatment and study plan

Titrated Opioid Sparing Anesthesia

Procedure

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

Procedure

anesthesia performed without opioid administration

Primary outcomes

  1. 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)

    Time frame: During the first 24 hours after the start of anesthesia

Secondary outcomes

  1. Stability of heart rate (HR) and mean arterial pressure (MAP)

    Time frame: During intervention

    • 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

  2. Speed of emergence from anesthesia in the post-anesthesia care unit (PACU)

    Time frame: Time interval between the end of the procedure and extubation

  3. Postoperative pain control

    Time frame: During awakening, at day 1 and day 2 after surgery

    Maximum pain score on a 0-10 numerical rating scale (NRS max) in the PACU

  4. Adverse effects of postoperative opioids

    Time frame: During the awakening

    Number of hypoxia episodes in the PACU (hypoxia defined as SpO2 ≤ 94% on room air)

  5. Discharge from the hospital is possible as early as 24 hours post-procedure for patients deemed eligible for early discharge (determined by the surgeon prior to the intervention).

    Time frame: Until 24 hours after surgery

  6. Patient satisfaction: satisfaction questionnaire (completed on the day of discharge) regarding the management of any pain.

    Time frame: At discharge (between 24 and 48 hours after surgery)

  7. Maximum pain score on a 0-10 numerical rating scale (NRS max) at rest and during movement

    Time frame: On postoperative days 1 and 2

  8. IV morphine dose received in the PACU, expressed in MME

    Time frame: during the awakening

  9. Morphine dose received in the surgical ward, expressed in MME, at 6, 12, 18, 24, 36, and 48 hours post-surgery (H0 = start of surgery)

    Time frame: Every 6 hours until 48 hours after surgery

  10. Number of patients not receiving morphine in the PACU

    Time frame: during the awakening, 24 hours after surgery, 48 hours after surgery

  11. Presence of postoperative nausea and/or vomiting (PONV)

    Time frame: Until up to 48 hours after surgery

  12. Acute urinary retention (defined by the presence of a bladder volume > 600 ml requiring urinary catheterization)

    Time frame: Until up to 48 hours after surgery

  13. Postoperative confusional state: preoperative cognitive test (Mini-Cog) and screening for postoperative confusional state (Confusion Assessment Method, CAM)

    Time frame: After surgery just before discharge (between 24 and 48 hours after surgery)

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Yves JY Martinez, Doctor

CONTACT

[email protected]

+33 2 38 79 61 85

Sponsors and collaborators

Lead sponsor

Pole Sante Oreliance, Polyclinique des Longues Allees

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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