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临床试验/NCT03566628
NCT03566628Unknown不适用

Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography: A Randomised Trial

Universidad de Valparaiso2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Postprocedural Shivering

研究概览

简要总结

This study evaluates whether the use of warmed solutions during cerebral angiography reduces the incidence of post-anaesthetic shivering. Half of participants will receive pre-warmed (39ºC) isotonic saline, while the other half receives the same solution at room temperature.

详细描述

Shivering is a physiologic reaction aimed at raising body temperature that is very common amongst patients undergoing cerebral angiographies. The use of pre-warmed solutions during the procedure may reduce the incidence of shivering amongst these patients. In this triple-blind randomised trial, a consecutive sample of participants receiving total intravenous anaesthesia (TIVA) and undergoing cerebral angiography will be allocated to receive a warmed (39ºC) solution of up to 500cc of isotonic saline or the same solution, but at room temperature. Patients requiring sedation, those expected to require mechanical ventilation after the procedure, those with diminished consciousness (Glasgow Coma Scale <15 pts) and patients not wishing to participate will be excluded from the study. The primary endpoint for this study is the incidence of shivering up to 60 minutes after the procedure is completed. Shivering will be assessed using a validated scale by operators unaware of treament allocation. All analyses will be undertaken by a statistician that will not participate of the clinical assessment of included patients.

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
Quadruple (Participant, Care Provider, Investigator, 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

  • Patients receiving TIVA
  • Patients undergoing cerebral angiography

排除标准

  • Glasgow Coma Scale <15 points prior to procedure
  • Expected need of mechanical ventilation after procedure completion
  • Use of sedatives
  • Refusal to participate

研究组 & 干预措施

Warmed Saline

Experimental

Patients allocated to this arm will receive a warmed (39ºC) solution of up to 500mL of isotonic saline. This solution will be administered directly to the cerebral vasculature as part of the angiography.

干预措施: Warmed Isotonic Saline (Other)

Room-Temperature Saline

Active Comparator

Patients allocated to this arm will receive isotonic saline at room temperature. This solution will be administered directly to the cerebral vasculature as part of the angiography.

干预措施: Room-Temperature Isotonic Saline (Other)

结局指标

主要结局

Postprocedural Shivering

时间窗: up to 60 minutes

Once the procedure is completed, the patient will be extubated and the presence or absence of shivering will be recorded up to 60 minutes after the extubation with the Badjatia 2008 scale consisting of a gradual evaluation of 0 to 3 points. With scores greater or equal to 1, shivering is considered established.

次要结局

  • Shivering severity(60 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathalie Lopez

Principal Investigator

Universidad de Valparaiso

研究点 (2)

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