Edmundo Pereira de Souza Neto
Montauban, Tarn et Garonne, 82000, France
NCT Number: NCT05446623
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.
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Notify Me18 year–90 year
All sexes
Interventional
Phase 2 / Phase 3
Montauban, Tarn et Garonne, 82000, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: DEXDOR
The one in the OA group will be given a bolus of Sufentanil before and during the surgery.
Other names: Sufenta
Time frame: 60 minutes
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.
Time frame: 60 minutes
To assess the impact of the OFA protocol on Blood pressure (variation of Blood pressure measured in mmHg)
Time frame: 60 minutes
To assess the impact of the OFA protocol on heart rate (variation in heart rate measured in beats per minute)
Time frame: 48 hours
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").
Time frame: 48 hours
To assess the impact of OFA on the consumption of postoperative morphine (consumption in mg)
Centre Hospitalier de Montauban
Other
Comparative Study of General Anesthesia With or Without Opioid on the Cardiac Index During Total Hip Arthroplasty
Acronym: OFFLOW
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