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Hemodynamic and Cerebral Effects Evaluation in Anesthesia

NCT05445037 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-13

No results posted yet for this study

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.

Conditions

  • Hemodynamic Monitoring
  • Orthopedic Procedures

Interventions

DEVICE

hemodynamic continuous monitoring

Continuous monitoring will be done with clearsight continuously assessing blood pressure, cardiac output and heart rate; NIRS electrode to assess cerebral O2 saturation, peripheral O2 saturation, BIS value and axillary temperature.

DEVICE

Standard Monitoring

Standard monitoring will be done with non-invasive blood pressure, heart rate, NIRS electrode to access cerebral O2 saturation, peripheral O2 saturation, axillary temperature, BIS value. In addition, patients will use Clearsight, but the device will be blind to the anesthesiologist. Pressure monitoring will be every 5 min.

Sponsors & Collaborators

  • Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

    lead OTHER

Principal Investigators

  • João M Silva Junior, PhD · Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-16
Primary Completion
2024-04-01
Completion
2024-07-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445037 on ClinicalTrials.gov