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

NCT07747142 | Not Yet Recruiting

• 1 other identifier: ID-RCB-2026-A00810-51
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Total Hip Arthroplasty (THA)

Keywords

Cardean; OSA; OFA; anesthesia

Outcome Measures

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)

  During the first 24 hours after the start of anesthesia

Secondary Outcomes (13)

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

  During intervention

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

  Time interval between the end of the procedure and extubation

• Postoperative pain control

  During awakening, at day 1 and day 2 after surgery

• Adverse effects of postoperative opioids

  During the awakening

• 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).

  Until 24 hours after surgery

Study Arms (2)

Titrated Opioid Sparing Anesthesia

EXPERIMENTAL

Procedure: Titrated Opioid Sparing Anesthesia

Opioid Free Anesthesia

ACTIVE COMPARATOR

Procedure: opioid free anesthesia

Interventions

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).

Titrated Opioid Sparing Anesthesia

opioid free anesthesia PROCEDURE

anesthesia performed without opioid administration

Opioid Free Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pole Sante Oreliance, Polyclinique des Longues Allees: lead

Study Sites (1)

Pole Sante Oreliance, Polyclinique des Longues Allees

Saran, 45770, France

Location

Related Publications (15)

• Pedersen C, Vilhelmsen FJ, Laigaard J, Mathiesen O, Karlsen APH. Opioid consumption and non-opioid multimodal analgesic treatment in pain management trials after hip and knee arthroplasties: A meta-epidemiological study. Acta Anaesthesiol Scand. 2023 May;67(5):613-620. doi: 10.1111/aas.14213. Epub 2023 Feb 21.

  PMID: 36759566 BACKGROUND

• Laigaard J, Pedersen C, Ronsbo TN, Mathiesen O, Karlsen APH. Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review. Br J Anaesth. 2021 May;126(5):1029-1037. doi: 10.1016/j.bja.2021.01.021. Epub 2021 Mar 5.

  PMID: 33678402 BACKGROUND

• Wey PF, Loheas D, Lamblin A, Riche B, Rabilloud M, Escarment J, Puidupin M, Quintin L, Martinez JY, Cividjian A. A beat-by-beat cardiovascular index, CARDEAN, to titrate opioid administration in the setting of orthopaedic surgery: a prospective randomized trial. J Clin Monit Comput. 2021 Dec;35(6):1311-1324. doi: 10.1007/s10877-020-00597-6. Epub 2020 Oct 6.

  PMID: 33025323 BACKGROUND

• Papaioannou V, Chouvarda I, Gaertner E, Benyamina M, Ferry A, Maurel V, Soussi S, Blet A, Chaouat M, Plaud B, Mebazaa A, Legrand M; PRONOBURN Group. Heart rate variability and cardiac baroreflex inhibition-derived index predicts pain perception in burn patients. Burns. 2016 Nov;42(7):1445-1454. doi: 10.1016/j.burns.2016.04.017. Epub 2016 May 8.

  PMID: 27170468 BACKGROUND

• Rossi M, Cividjian A, Fevre MC, Oddoux ME, Carcey J, Halle C, Frost M, Gardellin M, Payen JF, Quintin L. A beat-by-beat, on-line, cardiovascular index, CARDEAN, to assess circulatory responses to surgery: a randomized clinical trial during spine surgery. J Clin Monit Comput. 2012 Dec;26(6):441-9. doi: 10.1007/s10877-012-9372-y. Epub 2012 Jun 10.

  PMID: 22684738 BACKGROUND

• Martinez JY, Wey PF, Lions C, Cividjian A, Rabilloud M, Bissery A, Bourdon L, Puidupin M, Escarment J, Quintin L. A beat-by-beat cardiovascular index, CARDEAN: a prospective randomized assessment of its utility for the reduction of movement during colonoscopy. Anesth Analg. 2010 Mar 1;110(3):765-72. doi: 10.1213/ANE.0b013e3181cc9ebe.

  PMID: 20185655 BACKGROUND

• Cividjian A, Martinez JY, Combourieu E, Precloux P, Beraud AM, Rochette Y, Cler M, Bourdon L, Escarment J, Quintin L. Beat-by-beat cardiovascular index to predict unexpected intraoperative movement in anesthetized unparalyzed patients: a retrospective analysis. J Clin Monit Comput. 2007 Apr;21(2):91-101. doi: 10.1007/s10877-006-9061-9. Epub 2006 Dec 22.

  PMID: 17186401 BACKGROUND

• Ao Y, Ma J, Zheng X, Zeng J, Wei K. Opioid-Sparing Anesthesia Versus Opioid-Free Anesthesia for the Prevention of Postoperative Nausea and Vomiting after Laparoscopic Bariatric Surgery: A Systematic Review and Network Meta-Analysis. Anesth Analg. 2025 Feb 1;140(2):385-396. doi: 10.1213/ANE.0000000000006942. Epub 2024 Apr 5.

  PMID: 38578868 BACKGROUND

• Collange V, Berruet JB, Aubrun F, Poiblanc M, Olagne E, Golliet Mercier N, Parent S, Noel P, Devillez S, Perrou M, Ramadan J, Coeckelenbergh S, Joosten A. Opioid free versus opioid sparing strategies for multimodal antinociception during laparoscopic colectomy: a randomised controlled trial. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101436. doi: 10.1016/j.accpm.2024.101436. Epub 2024 Oct 9.

  PMID: 39393528 BACKGROUND

• Salome A, Harkouk H, Fletcher D, Martinez V. Opioid-Free Anesthesia Benefit-Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 May 12;10(10):2069. doi: 10.3390/jcm10102069.

  PMID: 34065937 BACKGROUND

• Urvoy B, Aveline C, Belot N, Catier C, Beloeil H. Opioid-free anaesthesia for anterior total hip replacement under general anaesthesia: the Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement trial. Br J Anaesth. 2021 Apr;126(4):e136-e139. doi: 10.1016/j.bja.2021.01.001. Epub 2021 Feb 3. No abstract available.

  PMID: 33549323 BACKGROUND

• Beloeil H, Garot M, Lebuffe G, Gerbaud A, Bila J, Cuvillon P, Dubout E, Oger S, Nadaud J, Becret A, Coullier N, Lecoeur S, Fayon J, Godet T, Mazerolles M, Atallah F, Sigaut S, Choinier PM, Asehnoune K, Roquilly A, Chanques G, Esvan M, Futier E, Laviolle B; POFA Study Group; SFAR Research Network. Balanced Opioid-free Anesthesia with Dexmedetomidine versus Balanced Anesthesia with Remifentanil for Major or Intermediate Noncardiac Surgery. Anesthesiology. 2021 Apr 1;134(4):541-551. doi: 10.1097/ALN.0000000000003725.

  PMID: 33630043 BACKGROUND

• Chassery C, Atthar V, Marty P, Vuillaume C, Casalprim J, Basset B, De Lussy A, Naudin C, Joshi GP, Rontes O. Opioid-free versus opioid-sparing anaesthesia in ambulatory total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Feb;132(2):352-358. doi: 10.1016/j.bja.2023.10.031. Epub 2023 Dec 2.

  PMID: 38044236 BACKGROUND

• Albrecht E, Grape S, Frauenknecht J, Kilchoer L, Kirkham KR. Low- versus high-dose intraoperative opioids: A systematic review with meta-analyses and trial sequential analyses. Acta Anaesthesiol Scand. 2020 Jan;64(1):6-22. doi: 10.1111/aas.13470. Epub 2019 Oct 7.

  PMID: 31506922 BACKGROUND

• Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1.

  PMID: 30983591 BACKGROUND

Central Study Contacts

Jean-Yves JY Martinez, Doctor

CONTACT

+33 2 38 79 61 85; jyvesmartinez@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)