Cardiac Index and General Anesthesia Without Opioid.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Arthropathy, Hip Disease

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid free anesthesia (OFA)<br>The patients included in the OFA group will receive a bolus of Dexmedetomidine at the beginning of the surgery. | Drug: Dexmedetomidine<br>* 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.<br>* Other names: DEXDOR;|
| Sham Comparator: anesthesia with opioid (OA)<br>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<br>* The one in the OA group will be given a bolus of Sufentanil before and during the surgery.<br>* Other names: Sufenta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac index, total hip arthroplasty, opioid free anesthesia