跳至主要内容
临床试验/NCT03837145
NCT03837145Unknown不适用

Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients-An Observational Study

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Dosage of propofol in mg/kg/hr required for sedation (BIS:60-80) of postoperative electively ventilated living donor liver transplant recipients.

研究概览

简要总结

All consenting, adult patients aged 18 years and above who will require elective ventilation after liver transplant recipient surgery will be enrolled for the study. Patients in acute liver failure, hepatic encephalopathy or patients with history of allergic reactions to propofol will be excluded from the study. This is an observational study. As per institute treatment protocol, propofol will be given post-operatively at a dose of 1 mg/kg/hr and than titrated to maintain a Bi-Spectral Index (BIS) score of 60-80 till the patient is on ventilator. There will be no deviation from our routine institutional protocol and no other sedative drugs like opioids or benzodiazepines will be used and no interventions will be done. Hemodynamics will be maintained targeting a mean arterial pressure (MAP) of at least 65 mm Hg. during the study period using appropriate measures.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Living donor liver transplant (LDLT) recipient adult patients ≥ 18 years of age requiring postoperative elective ventilation.

排除标准

  • Propofol allergy
  • Acute liver failure (ALF).
  • Hepatic encephalopathy (HE)

结局指标

主要结局

Dosage of propofol in mg/kg/hr required for sedation (BIS:60-80) of postoperative electively ventilated living donor liver transplant recipients.

时间窗: up to 24 hours

Every 2 hrly , the continuous intravenous Propofol dose going on will be recorded.

次要结局

  • Correlation of propofol dose with respective arterial lactate levels every 2 hours during the period of elective ventilation(up to 24 hours)
  • Changes of propofol dose over the study period to maintain BIS between 60 -80(up to 24 hours)
  • Correlation of the mean dose of propofol in mg/kg/hr with Arterial ammonia at baseline and to see the association between immediate post operative and Postoperative day1 ammonia with corresponding propofol dose.(up to 24 hours)

研究者

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

Rishabh Jaju

senior resident

Institute of Liver and Biliary Sciences, India

研究点 (1)

Loading locations...

相似试验