CTRI/2017/12/011024招募中3 期
Effect of Dexmedetomidine as an adjuvant to Bupivacaine for scalp blocks in supratentorial craniotomy.
Sree Chitra Tirunal Institute for Medical Sciences and Technology1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Duration of post-operative analgesia, defined as the time when the Visual Analog Score is greater than or equal to 4 in the post operative period
研究概览
简要总结
Primary purpose of the study is to evaluate the effect of adding Dexmedetomidine as an adjuvant to scalp block, with respect to its effect on the duration of scalp block.Dexmedetomidine as an adjuvant to scalp block will prolong the duration of scalp block, thereby increasing the duration of the block, and therefore, decreasing the requirement of analgesic use in the post operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting, non pregnant, non lactating adult patients coming for supratentorial craniotomy will participate in the study.
- •Minors, neonates, persons incompetent to give informed consent, prisoners, normal/healthy volunteer, student, staff of the institute are not planned to be included in the study.
排除标准
- •Previous craniotomy,Hypertensive patients, Diabetics, Pre-operative GCS < 15/15, Known allergy to local anaesthetics, Pregnancy, Scalp infection, Coagulopathy.
结局指标
主要结局
Duration of post-operative analgesia, defined as the time when the Visual Analog Score is greater than or equal to 4 in the post operative period
时间窗: Visual Analog Score to be assessed post operatively at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours and 24 hours.
次要结局
- Post operative sedation score; Ramsay Sedation Scale(Every hour for 6 hours post operatively)
- Intra-operative anaesthetic requirement; Number of additional doses of Fentanyl required to ensure adequate intraoperative analgesia(At the end of surgery)
- Post-operative analgesia(VAS score)
研究者
研究点 (1)
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