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临床试验/CTRI/2015/06/005888
CTRI/2015/06/005888已完成不适用

Comparison of efficacy of dexmedetomedine and subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block: A randomized trial

Mahatma Gandhi medical college and research institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月7日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
1. Degree of sedation

研究概览

简要总结

Subanaesthetic doses of  Ketamine has been tried for procedural sedation in the past.1, 2 Dexmedetomidine is increasingly used as a sedative drug for procedural sedation in various surgeries in recent times.3.4 There are no studies in literature comparing ketamine and dexmedetomedine  for allaying procedural discomfort. So we would like to compare the efficacy of dexmeditomedine and  subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block

  Aims and objectives; To compare the efficacy of dexmeditomedine and  subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block with regard to 1. Degree of sedation, 2. Ease of positioning, 3. Prick response 3. Time interval between study drug injection and response to verbal commands 4. Complications 5. Recall of procedure, 6. Patient satisfaction

hypothesis: dexmeditomedine is better than  subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Willingness.
  • ASA 1 & 2 physical status.
  • Age 18 to 50 years.

排除标准

  • Allergic to drugs used.
  • Psychiatric disorder.
  • Patients on beta blocker therapy.
  • Contraindicated to SAB.

结局指标

主要结局

1. Degree of sedation

时间窗: 1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block

2. Ease of positioning

时间窗: 1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block

3. Prick response

时间窗: 1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block

4.Time interval between study drug injection and response to verbal commands

时间窗: 1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block

5. Recall of procedure

时间窗: 1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block

6. Patient satisfaction

时间窗: 1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block

次要结局

  • 1. complications(2. hemodynamic variation from drug administraion to patient positioning after subarachnoid block)

研究者

申办方类型
Other [institute]

研究点 (1)

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