Comparision of sub-anaesthetic dose of intravenous ketamine plus lignocaine versus lignocaine scalp block in blunting the sympathetic response to skull pin head holder application for elective.craniotomy- a non inferiority trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Subanesthetic dose of intravenous ketamine with lignocaine is non-inferior to scalp block in blunting the hemodynamic responses to skull pin application for craniotomy.
研究概览
简要总结
Application of skull pin head holder in craniotomies is routinely used which elicits a roboust sympathetic response which has the potential to affect the homeostasis negatively one of the principles of anaesthesia is to ensure adequate analgesia and patients undergoing surgeries will be voluntarily enrollled after they meet the inclusion criteria and will be randomised into two groups one with intravenous lignocaine and ketamine whilst the other into scalp block group
hemodynamic changes will be noted when the skull pin head holder is applied and intermittently until the next fifteen minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •a.Patients in age group 18-60 years, both males and females.
- •b.Patients posted for elective craniotomy.
- •Patients with ASA PS 1-3.
排除标准
- •a.Patients with pre-operative GCS less than 8/
- •c.Patients with co-morbidities like uncontrolled hypertension, coronary artery disease, heart failure,chronic liver disease, BMI greater than 30kg/m2, seizure disorders.
- •d.Pregnant women.
结局指标
主要结局
Subanesthetic dose of intravenous ketamine with lignocaine is non-inferior to scalp block in blunting the hemodynamic responses to skull pin application for craniotomy.
时间窗: The heart rate and blood pressure will be measured in both the groups of patient immediately after application of skull pin head holder and there after at 1 minute 2 minutes 5 minutes 10 minutes and 15 minutes
次要结局
- Quantifying the requirement of rescue intravenous fentanyl boluses in both the groups(At the end of 15 minutes after the application of skull pin head holder)
研究者
Dr Kruti Jain
All India Institue of Medical Sciences, Raipur