跳至主要内容
临床试验/NCT06243822
NCT06243822已完成4 期

Hemodynamic Effects of Ketamine Compared With Propofol as Continuous ICU Sedation in Mechanically Ventilated Patients

Menoufia University1 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1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
heart rate

研究概览

简要总结

this study is to assess the hemodynamic profile of ketamine compared with propofol in critically ill, mechanically ventilated adult Patients study will be carried out on 100 mechanically ventilated patients who received one sedative agent propofol or ketamine The patients will be randomized into two equal groups to receive either ketamine or propofol Group 1 (Ketamine group): ketamine is initiated at 0.5 mg/kg/h and titrated by 0.25 mg/kg/h every 15 minutes to a maximum dosage of 4 mg/kg/h to achieve appropriate sedation. Group 2 (Propofol group): Propofol is initiated at 0.3 to 0.6 mg /kg/hr. and titrated by 0.3 to 0.6 mg/kg/h every 5 to 10 minutes up to a maximum dosage of 4.5 to 4.8 mg/kg/hr. to achieve appropriate sedation.

研究设计

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

入排标准

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

入选标准

  • mechanically ventilated, and receive sedation with continuous infusion propofol, or ketamine for at least 24 hours

排除标准

  • Receiving propofol or ketamine concurrently.
  • Transferred from an outside hospital on sedation.
  • Receiving ketamine for an indication other than sedation.
  • Daily intake of opioids.
  • Contraindication to any drug used in the study.

研究组 & 干预措施

Ketamine group

Active Comparator

干预措施: Ketamine (Drug)

propofol group

Active Comparator

干预措施: Propofol (Drug)

结局指标

主要结局

heart rate

时间窗: every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours

measure heart rate

mean arterial blood pressure

时间窗: every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours

measure mean arterial blodd pressure

次要结局

未报告次要终点

研究者

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

mostafa saieed fahim mansour

lecturer of anaesthesiology

Menoufia University

研究点 (1)

Loading locations...

相似试验