Cardiac Index and General Anesthesia Without Opioid.

NCT05446623 | Completed Phase 2

• 1 other identifier: 2020-A02873-36
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia used to be based on the association of hypnotics and opioid drugs. But recent studies showed that opioids may be related to a many different complications, like respiratory distress, hyperalgesia. Opioid free anesthesia (OFA) aim is to control de cardiovascular nociceptive response to the surgical stimulation. The scientific literature is not clear yet on the cardiovascular effect of the OFA. Optimization of the cardiac index proved its worth in reducing morbidity and mortality. The purpose of this study is to increase our understanding of the impact of opioid free anesthesia on the cardiovascular system and to evaluate the effectiveness and the security of the technic.

Conditions

Hip Arthropathy; Hip Disease

Keywords

cardiac index; total hip arthroplasty; opioid free anesthesia

Outcome Measures

Primary Outcomes (1)

• the impact of opioid free anesthesia on the cardiac index

  The main objective of this study is to evaluate the impact of opioid free anesthesia on the cardiac index and comparing it to the general anesthesia protocol with opioids.

  60 minutes

Secondary Outcomes (4)

• Assess the impact of the OFA in hemodynamical state

  60 minutes

• Assess the impact of the OFA protocol on heart rate

  60 minutes

• Assess the impact of OFA on postoperative pain

  48 hours

• Assess the impact of OFA on the consumption of postoperative morphine

  48 hours

Study Arms (2)

Opioid free anesthesia (OFA)

ACTIVE COMPARATOR

The patients included in the OFA group will receive a bolus of Dexmedetomidine at the beginning of the surgery.

Drug: Dexmedetomidine

anesthesia with opioid (OA)

SHAM COMPARATOR

The one in the OA group will be given a bolus of Sufentanil before and during the surgery. When the specific sequence will be completed, the care of all the patient will return to usual.

Drug: Sufentanil

Interventions

Dexmedetomidine DRUG

Opioid free anesthesia (OFA) consists in the simultaneous administration of alpha2-agonist (for example the dexmedetomidine), sodium channel blocker (lidocaine), and NMDA antagonists receptors (Ketamine). Its aim is to control de cardiovascular nociceptive response to the surgical stimulation.

Also known as: DEXDOR

Opioid free anesthesia (OFA)

Sufentanil DRUG

The one in the OA group will be given a bolus of Sufentanil before and during the surgery.

Also known as: Sufenta

anesthesia with opioid (OA)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients for scheduled total hip arthroplasty with general anesthesia.
• Patients with an American Society of Anesthesiologists (ASA) score between 1 and 3
• Patient who has received appropriate information and has provided informed consent.
• Patient with French social security system.

You may not qualify if:

• Patients eligible to rapid sequence intubation.
• Patients with medical contraindication to the use of OFA : allergy to one of the drug used in the protocol, spontaneous bradycardia under 40bpm or atrioventricular block.
• Patients with a medical condition that could alter measurement of cardiac index by NICCOMO™: acute pulmonary oedema, severe valvular heart disease, pulmonary hypertension, atrial fibrillation.
• Patients who cannot give their informed consent.
• Patients pregnant or breastfeeding.
• Patients odler than 90 years old or with a weigh superior at 150kg.

Sponsors & Collaborators

• Centre Hospitalier de Montauban: lead

Study Sites (1)

Edmundo Pereira de Souza Neto

Montauban, Tarn et Garonne, 82000, France

Location

Related Publications (15)

• Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.

  PMID: 18443635 BACKGROUND

• Yi P, Pryzbylkowski P. Opioid Induced Hyperalgesia. Pain Med. 2015 Oct;16 Suppl 1:S32-6. doi: 10.1111/pme.12914.

  PMID: 26461074 BACKGROUND

• Lavand'homme P, Estebe JP. Opioid-free anesthesia: a different regard to anesthesia practice. Curr Opin Anaesthesiol. 2018 Oct;31(5):556-561. doi: 10.1097/ACO.0000000000000632.

  PMID: 29994942 BACKGROUND

• Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24.

  PMID: 29739542 BACKGROUND

• Mulier JP. Is opioid-free general anesthesia for breast and gynecological surgery a viable option? Curr Opin Anaesthesiol. 2019 Jun;32(3):257-262. doi: 10.1097/ACO.0000000000000716.

  PMID: 31045633 BACKGROUND

• Beloeil H. Opioid-free anesthesia. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):353-360. doi: 10.1016/j.bpa.2019.09.002. Epub 2019 Sep 26.

  PMID: 31785720 BACKGROUND

• Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.

  PMID: 32530891 BACKGROUND

• Bugada D, Lorini LF, Lavand'homme P. Opioid free anesthesia: evidence for short and long-term outcome. Minerva Anestesiol. 2021 Feb;87(2):230-237. doi: 10.23736/S0375-9393.20.14515-2. Epub 2020 Aug 4.

  PMID: 32755088 BACKGROUND

• Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.

  PMID: 29739537 BACKGROUND

• Kharasch ED, Clark JD. Opioid-free Anesthesia: Time to Regain Our Balance. Anesthesiology. 2021 Apr 1;134(4):509-514. doi: 10.1097/ALN.0000000000003705. No abstract available.

  PMID: 33630018 BACKGROUND

• Forget P. Opioid-free anaesthesia. Why and how? A contextual analysis. Anaesth Crit Care Pain Med. 2019 Apr;38(2):169-172. doi: 10.1016/j.accpm.2018.05.002. Epub 2018 Sep 13.

  PMID: 29775728 BACKGROUND

• Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.

  PMID: 25925031 BACKGROUND

• Tempe DK, Sawhney C. Opioid-Free Anesthesia for Thoracic Surgery: A Step Forward. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3041-3043. doi: 10.1053/j.jvca.2020.07.022. Epub 2020 Jul 10. No abstract available.

  PMID: 32739086 BACKGROUND

• Siu EY, Moon TS. Opioid-free and opioid-sparing anesthesia. Int Anesthesiol Clin. 2020 Spring;58(2):34-41. doi: 10.1097/AIA.0000000000000270. No abstract available.

  PMID: 32004171 BACKGROUND

• Chakravarthy M. Opioid free cardiac anesthesia - A flash in the pan? Ann Card Anaesth. 2020 Apr-Jun;23(2):113-115. doi: 10.4103/aca.ACA_68_19. No abstract available.

  PMID: 32275021 BACKGROUND

Related Links

• The Benefits of Opioid Free Anesthesia and the Precautions Necessary When Employing It. Transl Perioper Pain Med

MeSH Terms

Interventions

Dexmedetomidine; Sufentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized into two groups depending on the type of general anesthesia: Opioid free anesthesia (OFA), or anesthesia with opioid (OA)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a monocentric, randomized study comparing two strategies of general anesthesia for programmed total hip arthroplasty. Patients who gave their consent for the study during the anesthesia consultation, will be randomized into two groups depending on the type of general anesthesia: Opioid free anesthesia (OFA), or anesthesia with opioid (OA) The patients included in the OFA group will receive a bolus of Dexmedethomidine at the beginning of the surgery. The one in the OA group will be given a bolus of Sufentanil before and during the surgery. When the specific sequence will be completed, the care of all the patient will return to usual. During the anesthesia induction and during the surgery cardiovascular data will be collected. The cardiac index will be measured thanks to a non invasive cardiac monitoring called NICCOMO® (v3.5.2).

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: July 6, 2022
• Study Start: January 1, 2021
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)