Hemodynamic and Cerebral Effects Evaluation in Anesthesia

NCT ID: NCT05445037

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-16
• Study Completion Date: 2024-07-01

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.

Detailed Description

The study will be split in 4 groups, being group 1A general anesthesia plus interscalene brachial plexus block with continuos non-invasive monitoring, group 1B general anesthesia plus interscalene brachial plexus block with standard hemodynamic monitoring, group 2A sedation plus interscalene brachial plexus block with continuos non-invasive monitoring, gruop 2B sedation plus interscalene brachial plexus block with standard hemodynamic monitoring.

The standard hemodynamic monitoring includes blood pressure, heart rate, peripheral oxygen saturation, brain monitoring and cerebral oxygen saturation. The continuos non-invasive monitoring includes the standard monitoring plus cardiac output, cardiac index and hypotension predict index. These variables will be analyzed intraoperatively and compared between groups with the aim of demonstrating the benefit of continuous non-invasive monitoring.

In the postoperative will be evalueted delirium, lenght hospital stay, postoperative complication and pain. We will use the Richmond Agitation Sedation Scale (RASS), Confusion Assessment Method in the ICU, visual analogue pain scale and visual numeric pain scale for evaluation postoperative.

Conditions

Hemodynamic Monitoring; Orthopedic Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

hemodynamic continuous monitoring

Intervention Type: 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.

Standard monitoring

Standard monitoring will be done with non-invasive

Group Type: EXPERIMENTAL

Standard Monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

João manoel Silva Junior

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

João M Silva Junior, PhD

Role: STUDY_DIRECTOR

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Locations

Hospital do Servidor Público Estadual de São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Lia AM Mota Lustosa, Doctor

Role: CONTACT

liaamartinss@hotmail.com

+55 85 981665502

Facility Contacts

João M Silva Júnior, PhD

Role: primary

joao.s@globo.com

+5511993521494

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

USP

Identifier Type: -

Identifier Source: org_study_id