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临床试验/NCT05786365
NCT05786365已完成不适用

Comparison of Emergence/Dysphoric Reaction Frequency of Using Ketamine at 2 Different Doses in Interventional Sedation and Analgesia

Aksaray University Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年1月1日最近更新:
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
发起方
入组人数
108
试验地点
1
主要终点
To observe a significant difference between the two doses in terms of producing a dysphoric reaction

研究概览

简要总结

The aim of this study is to compare the effect of using different doses of ketamine on producing dysphoric reaction.

详细描述

Our study is a randomized single-blind observational study. In our study, the effect of producing a dysphoric reaction will be observed by administering ketamine at doses of 0.5 mg/kg and 1 mg/kg to two randomly randomized different groups who presented to our hospital and needed interventional sedation analgesia. For this reason, our patients with an indication for interventional sedation and analgesia will be taken to the observation room and their vital values will be monitored. Two different vascular accesses with at least 18 gauge will be obtained from the two extremities. The patients will be randomized and 0.5 mg/kg IV ketamine will be given to the 1st group. The second group will be given 1 mg/kg IV ketamine. Then, the patients will be recorded in terms of blood pressure, pulse and saturation at the 5th minute, 15th minute and 30th minute. We will give iv ketamine to two different patient groups as 0.5 mg per kilogram in the 1st group and 1 mg per kilogram in the 2nd group and we will observe the patients.We scored the patients between +4 and -5 points on the RASS scale. Patients who were sedated to an extent that they could not be awakened were scored as -5, patients who were dangerously agitated +4, and patients who were awake were scored 0. We considered patients who scored +2 on the Richmond agitation sedation scale as having developed a dysphoric reaction.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Glaskow coma scale should be 15
  • Inability to speak, read or understand English or Turkish
  • Patients needing procedural sedation and analgesia

排除标准

  • Patients with active coronary artery disease
  • Patients with liver or kidney transplant
  • Patients with conditions that change consciousness such as substance intake, alcohol intake
  • Patients with advanced COPD or Heart failure

研究组 & 干预措施

The group given 0.5 mg/kg ketamine

In this group we will give 0.5 mg/kg ketamine and we observe for disphoric reaction

干预措施: Ketalar 50 MG/ML Injectable Solution (Drug)

The group given 1 mg/kg ketamine

In this group we will give 1 mg/kg ketamine and we observe for disphoric reaction

干预措施: Ketalar 50 MG/ML Injectable Solution (Drug)

结局指标

主要结局

To observe a significant difference between the two doses in terms of producing a dysphoric reaction

时间窗: January 2023-August 2023

We will give iv ketamine to two different patient groups as 0.5 miligram/kilogram in the 1st group and 1 miligram/kilogram in the 2nd group and we will observe the patients.We scored the patients between +4 and -5 points on the Richmond Agitation and Sedation Scale between -5 to +4. Patients who were sedated to an extent that they could not be awakened were scored as -5, patients who were dangerously agitated +4, and patients who were awake were scored 0. We considered patients who scored +2 on the Richmond agitation sedation scale as having developed a dysphoric reaction.

次要结局

  • Efficacy of 0.5 mg/kg and 1 mg/kg IV ketamine(January 2023-August 2023)

研究者

发起方
Aksaray University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

çağrı türkücü

cagriturkucu

Aksaray University Training and Research Hospital

研究点 (1)

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