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NCT05445037
Hemodynamic and Cerebral Effects Evaluation in Anesthesia
NA trial testing hemodynamic continuous monitoring in Hemodynamic Monitoring in 100 participants. Status unknown.
1 April 2024
Quick facts
| Lead sponsor | Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 16 October 2022 |
| Primary completion | 1 April 2024 |
| Estimated completion | 1 July 2024 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- hemodynamic continuous monitoring
- Standard Monitoring
Conditions studied
- Hemodynamic Monitoring — all drugs for Hemodynamic Monitoring →
- Orthopedic Procedures — all drugs for Orthopedic Procedures →
Sponsor
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Who can join
18 and older, any sex, with Hemodynamic Monitoring or Orthopedic Procedures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05445037
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Related trials
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Currently open trials in the same condition.
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- NCT07062744 — The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock · NA · recruiting
- NCT06918301 — Comparison of Cardiac Index and Stroke-volume-index Measured by Pulmonary Artery Catheter, FloTrac® and Argos® in Cardia · recruiting
- NCT07270341 — Evaluation of Cerebral Oxygenation During Orthopedic Surgeries Performed in the Beach Chair Position Under General Anest · recruiting
- NCT04281771 — Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI · NA · active not recruiting
Other Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo trials
Trials by the same sponsor.
- NCT03128190 — Multi-center Trial of Goal-directed Fluid Management Based on Pulse Pressure Variation Monitoring · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05445037 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Last refreshed: 13 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05445037.
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