Hemodynamic and Cerebral Effect of General Anesthesia Plus Block Interescalenic vs Sedation Plus Block Interescalenic: The Recognised Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Undergoing arthroscopic shoulder surgery in a beach chair position.

Locations
Other Locations
Brazil
Hospital do Servidor Público Estadual de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Lia AM Mota Lustosa, Doctor
liaamartinss@hotmail.com
+55 85 981665502
Time Frame
Start Date: 2022-10-16
Estimated Completion Date: 2024-07-01
Participants
Target number of participants: 100
Treatments
Experimental: Continuos Monitoring
Continuos monitoring will be done with clearsight continuously assessing blood pressure, cardiac output and heart rate; NIRS electrode to access cerebral O2 saturation, peripheral O2 saturation, BIS value and axillary temperature.
Experimental: Standard monitoring
Standard monitoring will be done with non-invasive
Related Therapeutic Areas
Sponsors
Leads: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

This content was sourced from clinicaltrials.gov

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