CompletedPhase 2Other

Cardiac Index and General Anesthesia Without Opioid.

NCT ID

NCT05446623

Target Enrollment

120 participants

Start Date

2021-01-01

Est. Completion

2024-10-02

About This Study

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.

Conditions Studied

Hip ArthropathyHip Disease

Interventions

•Dexmedetomidine
•Sufentanil

Eligibility

Age:18 Years - 90 Years

Healthy Volunteers:Yes

View full 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.

Study Locations (1)

Edmundo Pereira de Souza Neto

Montauban, Tarn et Garonne, France