Hip Arthropathy Clinical Trial
— OFFLOWOfficial title:
Comparative Study of General Anesthesia With or Without Opioid on the Cardiac Index During Total Hip Arthroplasty
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 2, 2024 |
Est. primary completion date | October 2, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | Edmundo Pereira de Souza Neto | Montauban | Tarn Et Garonne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier de Montauban |
France,
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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. — View Citation
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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. — View Citation
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. — View Citation
Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assess the impact of the OFA in hemodynamical state | To assess the impact of the OFA protocol on Blood pressure (variation of Blood pressure measured in mmHg) | 60 minutes | |
Secondary | Assess the impact of the OFA protocol on heart rate | To assess the impact of the OFA protocol on heart rate (variation in heart rate measured in beats per minute) | 60 minutes | |
Secondary | Assess the impact of OFA on postoperative pain | To assess the impact of OFA on postoperative pain (variation in numeric rating scales) From 0 to 10 => Zero represents "no pain," whereas 10 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain"). | 48 hours | |
Secondary | Assess the impact of OFA on the consumption of postoperative morphine | To assess the impact of OFA on the consumption of postoperative morphine (consumption in mg) | 48 hours |
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