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临床试验/NCT05445037
NCT05445037Unknown不适用

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

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Compare intraoperative hemodynamic changes: heart rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing arthroscopic shoulder surgery in a beach chair position.

排除标准

  • 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.

研究组 & 干预措施

Standard monitoring

Experimental

Standard monitoring will be done with non-invasive

干预措施: Standard Monitoring (Device)

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.

干预措施: hemodynamic continuous monitoring (Device)

结局指标

主要结局

Compare intraoperative hemodynamic changes: heart rate

时间窗: 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

时间窗: 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

时间窗: Intraoperative

Compare changes in cerebral tissue saturation between groups

Compare intraoperative hemodynamic changes: cardiac output

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

João manoel Silva Junior

PhD

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

研究点 (2)

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