Hemodynamic and Cerebral Effects Evaluation in Anesthesia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodynamic Monitoring; Orthopedic Procedures
• Intervention / Treatment: Device: hemodynamic continuous monitoring; Device: Standard Monitoring

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lia AM Mota Lustosa, Doctor; Phone Number: +55 85 981665502; Email: liaamartinss@hotmail.com

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04039901
      • Recruiting
      • Hospital do Servidor Público Estadual de São Paulo
      • Contact: João M Silva Júnior, PhD; Phone Number: +5511993521494; Email: joao.s@globo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Experimental: Standard monitoring; Standard monitoring will be done with non-invasive	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
• Investigators: Study Director: João M Silva Junior, PhD, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: USP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No