Evaluating hemodynamic and cerebral effects during shoulder anesthesia
Hemodynamic and Cerebral Effect of General Anesthesia Plus Block Interescalenic vs Sedation Plus Block Interescalenic: The Recognised Randomized Controlled Trial
NA · Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo · NCT05445037
This study is testing two different anesthesia methods for shoulder surgery to see which one helps patients feel better and recover faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo (other) |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT05445037 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the hemodynamic changes and cerebral oxygenation during arthroscopic shoulder surgeries using two anesthetic techniques: interscalene block with sedation and interscalene block with general anesthesia. Participants will be monitored using either continuous non-invasive monitoring or standard hemodynamic monitoring to assess cardiac output, blood pressure, heart rate, and oxygen saturation. The study will analyze these variables intraoperatively and evaluate postoperative outcomes such as delirium, hospital stay length, complications, and pain levels. The goal is to determine the benefits of continuous non-invasive monitoring in improving patient outcomes during these procedures.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective arthroscopic shoulder surgery in a beach chair position.
Not a fit: Patients undergoing emergency surgeries or those with significant comorbidities such as pulmonary disease or previous cerebrovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient safety and recovery during shoulder surgeries by optimizing hemodynamic management.
How similar studies have performed: Previous studies have shown promising results with continuous non-invasive monitoring in various surgical settings, suggesting potential benefits in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, SP
- Hospital do Servidor Público Estadual de São Paulo — São Paulo, SP, Brazil (RECRUITING)
Study contacts
- Study coordinator: Lia AM Mota Lustosa, Doctor
- Email: liaamartinss@hotmail.com
- Phone: +55 85 981665502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemodynamic Monitoring, Orthopedic Procedures