Hemodynamic Monitoring Clinical Trial
Official title:
Hemodynamic and Cerebral Effect of General Anesthesia Plus Block Interescalenic vs Sedation Plus Block Interescalenic: The Recognised Randomized Controlled Trial
NCT number | NCT05445037 |
Other study ID # | USP |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 16, 2022 |
Est. completion date | July 1, 2024 |
Recently, there has been an increase in the popularity of minimally invasive surgical techniques, including arthroscopic surgeries for shoulder procedures. Interscalene block is currently the gold standard technique for these surgeries, combined or not with general anesthesia. The last, when used in patients positioned in a beach chair can lead to serious hemodynamic and cerebral changes in the patients. Continuous non-invasive monitoring of the patient's cardiac output can provide data for better hemodynamics management compared to standard monitoring. Therefore, the aim of the study is to compare hemodynamic changes (cardiac output, blood pressure, heart rate, oxygen saturation) and intraoperative cerebral oxygenation using peripheral cerebral saturation monitoring with continuous measurement of cardiac output or standard hemodynamic between two anesthetic techniques for shoulder surgery: interscalene block with sedation versus interscalene block with general anesthesia. The groups will be evaluated as follows: group 1 general anesthesia plus interscalene brachial plexus block and group 2 sedation plus interscalene brachial plexus block. Additionally, each group will be subdivided into two more groups, one with continuous hemodynamic monitoring and the other with standard hemodynamic monitoring, that is, a total of 4 groups in the study. The analyzed variables will include gender, age, ASA, medications in use, comorbidities. Furthermore, duration of procedure and in the anesthetic recovery room, blood pressure, heart rate, cardiac output, peripheral oxygen saturation, cerebral oxygen saturation, BIS value, cardiac index, etCO2 will be evaluated. Besides, length of hospital stay, delirium, behavioral status and postoperative complication will also be assessed.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Undergoing arthroscopic shoulder surgery in a beach chair position. Exclusion Criteria: - Emergency surgery - Blood dyscrasia - Refusal of the procedure - Infection at the puncture site - Allergy to the medication used - Previous cerebrovascular disease - History of orthostatic hypotension - Pulmonary disease - Chronic use of opioids - Performance of arthroscopic surgeries on both shoulders - Refusal to participate in the study - Not to sign an informed consent form. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital do Servidor Público Estadual de São Paulo | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare intraoperative hemodynamic changes: cardiac output | Compare cardiac output changes between continuous hemodynamic measurement of cardiac output or standard hemodynamics monitoring in two anesthetic techniques for shoulder surgery: interscalene block with sedation versus interscalene block with general anesthesia. | Intraoperative | |
Primary | Compare intraoperative hemodynamic changes: blood pressure | Compare blood pressure changes between continuous hemodynamic measurement of cardiac output or standard hemodynamics monitoring in two anesthetic techniques for shoulder surgery: interscalene block with sedation versus interscalene block with general anesthesia. | Intraoperative | |
Primary | Compare intraoperative hemodynamic changes: heart rate | Compare heart rate changes between continuous hemodynamic measurement of cardiac output or standard hemodynamics monitoring in two anesthetic techniques for shoulder surgery: interscalene block with sedation versus interscalene block with general anesthesia. | Intraoperative | |
Primary | Evaluation of continuos hemodinamic monitoring non-invasive | Verify the superiority of continuos hemodynamic non-invasive monitoring of cardiac output compared to standard hemodynamic monitoring regarding blood pressure | Intraoperative | |
Primary | Evaluation of cerebral tissue saturation | Compare changes in cerebral tissue saturation between groups | Intraoperative |
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