Hemodynamic MonitoringNCT05445037
Hemodynamic and Cerebral Effects Evaluation in Anesthesia
A study testing hemodynamic continuous monitoring and Standard Monitoring in people with Hemodynamic Monitoring and Orthopedic Procedures, run by Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Monitoring, Orthopedic Procedures
- What is being tested?
- hemodynamic continuous monitoring and Standard Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Oct 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing arthroscopic shoulder surgery in a beach chair position.
Who cannot join
- Emergency surgery
- Blood dyscrasia
- Refusal of the procedure
- Infection at the puncture site
- Allergy to the medication used
- Previous cerebrovascular disease
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital do Servidor Público Estadual de São Paulo
São Paulo, São Paulo, 04039901
João M Silva Júnior, PhD, +5511993521494, joao.s@globo.com
About this study
Official title: 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.
Read the 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
- Being tested
- hemodynamic continuous monitoring, Standard Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodynamic continuous monitoringDevice
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 MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: hemodynamic continuous monitoring |
| Standard monitoring | Experimental | Standard monitoring will be done with non-invasive Receives: Device: Standard Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Intraoperative
Evaluation of cerebral tissue saturation
Compare changes in cerebral tissue saturation between groups
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start16 Oct 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João manoel Silva Junior, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Investigators
- João M Silva Junior, PhD, Study director, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445037
- Sponsor's protocol ID
- USP
- Status last verified
- Mar 2024
- First submitted
- 1 Jun 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Cerebral Effect of General Anesthesia Plus Block Interescalenic vs Sedation Plus Block Interescalenic: The Recognised Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05445037
- Acronym / sponsor ID
- USP
- Conditions
- Hemodynamic Monitoring, Orthopedic Procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao PauloUniversity, hospital or other
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuos Monitoring | Experimental | Device: hemodynamic continuous monitoringContinuos 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. |
| Standard monitoring | Experimental | Device: Standard MonitoringStandard monitoring will be done with non-invasive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing arthroscopic shoulder surgery in a beach chair position.
Key exclusion criteria (12 listed)
- Emergency surgery
- Blood dyscrasia
- Refusal of the procedure
- Infection at the puncture site
- Allergy to the medication used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemodynamic continuous monitoringContinuous 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 | Continuos Monitoring |
| Standard MonitoringStandard 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. | Device | Standard monitoring |
Primary outcome
Compare intraoperative hemodynamic changes: cardiac output
Time frame: Intraoperative
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.
Compare intraoperative hemodynamic changes: blood pressure
Time frame: Intraoperative
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.
Compare intraoperative hemodynamic changes: heart rate
Time frame: Intraoperative
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.
Evaluation of continuos hemodinamic monitoring non-invasive
Time frame: Intraoperative
Verify the superiority of continuos hemodynamic non-invasive monitoring of cardiac output compared to standard hemodynamic monitoring regarding blood pressure
Evaluation of cerebral tissue saturation
Time frame: Intraoperative
Compare changes in cerebral tissue saturation between groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João M Silva Junior, PhD study director
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemodynamic continuous monitoring and Standard Monitoring in people with Hemodynamic Monitoring and Orthopedic Procedures, run by Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lia AM Mota Lustosa, Doctor (+55 85 981665502, liaamartinss@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare intraoperative hemodynamic changes: cardiac output (time frame: Intraoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.