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临床试验/NCT02786264
NCT02786264已完成不适用

Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement

Yale University0 个研究点目标入组 186 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
186
主要终点
Procedure Length

研究概览

简要总结

This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral aortic valve replacements (TAVR) at Yale New Haven Hospital (YNHH).

详细描述

This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive TAVR at YNHH.

Hypothesis 1: TAVR surgery done under monitored anesthesia care are performed using some combination of the following anesthetics: dexmedetomidine, propofol, fentanyl, and midazolam.

Hypothesis 2: Age-adjusted dosing of these agents will be insufficient to account for extreme age after controlling for preoperative comorbid status.

Hypothesis 3: The rate of conversion to general anesthesia will be unrelated to the type of conscious sedation used.

Hypothesis 4: ICU length of stay, delirium, hospital length of stay, and length of hospital stay will be shorter for patients who were sedated using dexmedetomidine vs those without.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who underwent TAVR at YNHH under planned conscious sedation with monitored anesthetic care

排除标准

  • Patients who received monitored anesthesia care without the receipt of any study intervention drug (propofol, fentanyl, midazolam, or dexmedetomidine).

研究组 & 干预措施

Propofol-dominant Sedation

Patients receiving propofol infusion for TAVR as the primary drug for sedation.

干预措施: Propofol (Drug)

Dexmedetomidine-dominant Sedation

Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation.

干预措施: Dexmedetomidine with propofol (Drug)

Dexmedetomidine-dominant Sedation

Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation.

干预措施: Propofol (Drug)

结局指标

主要结局

Procedure Length

时间窗: During surgery

Procedure length will be collected from retrospective analysis of charts.

次要结局

  • Hospital Length of Stay(From the conclusion of surgery until patient is discharged, up to 2 weeks)
  • ICU Length of Stay(From the conclusion of surgery until patient leaves the ICU, up to 2 weeks)
  • Delirium Incidence(From the conclusion of surgery until patient is discharged, up to 2 weeks)
  • Rate of Conversion to General Anesthesia(During surgery)

研究者

申办方类型
Other
责任方
Sponsor

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