Clinical trial NCT05446623: Cardiac Index and General Anesthesia Without Opioid.
Official title: Comparative Study of General Anesthesia With or Without Opioid on the Cardiac Index During Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hip Arthropathy
Hip Disease
Keywords: cardiac index
total hip arthroplasty
opioid free anesthesia
Lead sponsor: Centre Hospitalier de Montauban
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the impact of opioid free anesthesia on the cardiac index
timeFrame: 60 minutes
Secondary outcomes:
measure: Assess the impact of the OFA in hemodynamical state
timeFrame: 60 minutes
measure: Assess the impact of the OFA protocol on heart rate
timeFrame: 60 minutes
measure: Assess the impact of OFA on postoperative pain
timeFrame: 48 hours
measure: Assess the impact of OFA on the consumption of postoperative morphine
timeFrame: 48 hours
Other outcomes:
Locations:
city: Montauban
country: France
facility: Edmundo Pereira de Souza Neto
state: Tarn Et Garonne
Study officials:
References:
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.
citation: Yi P, Pryzbylkowski P. Opioid Induced Hyperalgesia. Pain Med. 2015 Oct;16 Suppl 1:S32-6. doi: 10.1111/pme.12914.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.
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.