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NCT05446623 Clinical Trial

Cardiac Index and General Anesthesia Without Opioid.

Hip Arthropathy Clinical Trial

— OFFLOW  

Official title:
Comparative Study of General Anesthesia With or Without Opioid on the Cardiac Index During Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05446623
Other study ID # 2020-A02873-36
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 1, 2021
Est. completion date January 2, 2024

Study information
Verified date February 2023
Source Centre Hospitalier de Montauban
Contact Edmundo Souza Neto, PhD
Phone 33 7 70 01 72 59
Email edmundo.pereira-de-souza@hotmail.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

General anesthesia used to be based on the association of hypnotics and opioid drugs. But recent studies showed that opioïds may be related to a many different complications, like respiratory distress, hyperalgesia etc… Those sides effects are known, but there might be some recent technics that could allow anesthesiologist to reduce those unintended symptoms. As surgery became an important pilar of the modern medicine even in fragile people, the weight of opioids sides effect increased. Opioid free anesthesia (OFA) consists in the simultaneous administration of alpha2-agonist (for example the dexmedetomidine (DEXDOR)), sodium channel blocker (lidocaine), and N-methyl-D-aspartate (NMDA) antagonists receptors (Ketamine). Its 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 investigators thinks that exploring the impact of two different general anesthesia technics on cardiac index, might allow anesthesiologists to have a better understanding of the anesthetic strategy applied to the patient. General anesthesia with or without opioid is used on a daily basis at the hospital center of Montauban. The possible sides effects of OFA as well as those affiliate to balanced anesthesia are known by all the care workers. 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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Edmundo Pereira de Souza Neto Montauban Tarn Et Garonne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier de Montauban

Country where clinical trial is conducted

France, 

References & Publications (15)

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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

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

* Note: There are 15 references in all — Click here to view all references

Outcome
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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