Hemodynamic and Cerebral Effects Evaluation in Anesthesia

NCT05445037 | Recruiting DMC

• 1 other identifier: USP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Evaluation of cerebral tissue saturation

  Compare changes in cerebral tissue saturation between groups

  Intraoperative

Study Arms (2)

Continuos Monitoring

EXPERIMENTAL

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.

Device: hemodynamic continuous monitoring

Standard monitoring

EXPERIMENTAL

Standard monitoring will be done with non-invasive

Device: Standard Monitoring

Interventions

hemodynamic continuous monitoring DEVICE

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.

Continuos Monitoring

Standard Monitoring DEVICE

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.

Standard monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing arthroscopic shoulder surgery in a beach chair position.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital do Servidor Público Estadual de São Paulo

São Paulo, São Paulo, 04039901, Brazil

RECRUITING

Study Officials

• João M Silva Junior, PhD

  Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

  STUDY DIRECTOR

Central Study Contacts

Lia AM Mota Lustosa, Doctor

CONTACT

+55 85 981665502; liaamartinss@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: The selected patients will be divided into two groups: group 1 general anesthesia + interscalene brachial plexus block and group 2 sedation + interscalene brachial plexus block. Each group will be divided into two groups, one with hemodynamic continuous monitoring and one with standard hemodynamic monitoring, totaling 4 groups in total in the study. Group 1A general anesthesia + interscalene brachial plexus block with continuous monitoring; group 1B general anesthesia + interscalene brachial plexus block with standard monitoring; group 2A sedation + interscalene brachial plexus block with continuous monitoring; group 2B sedation + interscalene brachial plexus block with standard monitoring.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: July 6, 2022
• Study Start: October 16, 2022
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)