A randomized double blinded comparative study of Intravenous Enalapril with Clonidine for stress attenuation during intubation and prone positioning in spine surgeries
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Heart rate and BP variability
研究概览
简要总结
Patients suffering from spine problems, who are posted for spine surgeries in prone position, ASA I with no anticipated difficulty in intubation will be selected for the study.
These patients will be divided into two groups
-
Intervention group - These patients will be given Inj. Enalapril 1.25 milligram over 10 minutes
-
Comparator group - These patients will be given Inj. Clonidine 100 microgram over 10 minutes
For both the groups, general anaesthesia will be given according to standardised anaesthetic technique
Blood pressure and heart rate variability will be monitored during intubation and prone positioning
Hemodynamic status will be monitored throughout the surgery
Blood loss, Aldrete score and Surgeon’s opinion of the field will be assessed at the end of the surgery
Postoperative renal profile will be noted
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having problems in the spine (Lumbar and Thoracic) Age 18 to 70 years ASA 1 and 2 MPC 1 and 2 Willing to take part in the study.
排除标准
- •Patients who refuse the study Patients with known allergies to the study drugs Age >70 years Diabetic patients with autonomic dysfunction Hypertensive patients or those who on medications that influence blood pressure.
- •ASA III & IV, Mallampatti class III & IV Emergency procedures.
结局指标
主要结局
Heart rate and BP variability
时间窗: During tracheal intubation | During postural change (Supine to prone positioning)
次要结局
- Intra operative haemodynamics(Amount of intraoperative blood loss)