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临床试验/NCT05868642
NCT05868642已完成不适用

Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Nel Confronto Con la Tecnica Tradizionale Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. Trial Randomizzato Controllato

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2018年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
SBP change

研究概览

简要总结

Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia

详细描述

This study aims to investigate whether a different hemodynamic effect is related to the injection o titrated local anesthetic for subarachnoid anesthesia versus the conventional single shot injection. The data to be recorded are blood pressure and pulse rate at different timing. As secondary outcomes the investigators will record the anesthetic level achieved using the Bromage score.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •BMI 20-40 kg/m2
  • •undergoing total hip arthroplasty
  • •no controindications to subaracnhoid block
  • •able to understand and sign a written informed consensus
  • •METs > o = 4

排除标准

  • •baseline SBP < 100 mmHg

研究组 & 干预措施

T group

Experimental

Subaracnhoid block levobupivacaine 0.5%, 10 mg (2 ml) via subarachnoid injection plus 1mg for each metameric level needed to achieve the T10 level sensory block (evaluation with pinprick test at 10 minute after the firts injection and at 4 minute from the second injection)

干预措施: subarachnoid block (Procedure)

S group

Active Comparator

levobupivacaine 0.5%, 15 mg (3 ml) via subarachnoid injection

干预措施: subarachnoid block (Procedure)

结局指标

主要结局

SBP change

时间窗: 60 minute

SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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