A STUDY TO KNOW THE EFFICACY OF DEXMEDETOMIDINE AS AN ANTI SHIVERING AGENT FOLLOWING SPINAL ANAESTHESIA IN ADULTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.To study the efficacy of dexmedetomidine in prevention of shivering in adult patients undergoing surgeries under spinal anaesthesia
研究概览
简要总结
| Spinal anaesthesia is a procedure which is ubiquitous in every healthcare setup. From the day it was described by August Bier in 1898, this technique has undergone many modifications. The management of its complications have undergone many changes to make it more safer and acceptable. One of the complications which still haunts the anaesthesiologists and thus needs further modifications in its management is shivering. |
Shivering is a protective phenomenon which occurs when there is a drop in the core body temperature. As patients plunge into anaesthesia, shivering is always bound to happen and its avoidance is of prime importance.
The main control of temperature in human body is through the hypothalamus, which regulates body temperature between 36.50 to 37.50 Celsius and this is known as inter threshold range1. It is important to maintain this range of temperature for optimal metabolic and physiological functioning and any variations, will lead to derangement of these functions. During any form of anaesthesia there is an imbalance in the body’s ability to generate heat as compared to heat loss. In general anaesthesia use of inhalational anaesthetics, inhibition of autonomic system and behavioral responses makes patient suffer from hypothermia, whereas in spinal anaesthesia there is shift of heat to periphery from core2. Drugs used in treatment of shivering are:Tramadol,Pethidine,nefopam, physostigmine, ketamine, ondansetron, and granisetron3.
Many trials of dexmedetomidine in prevention of shivering after general anaesthesia have been done, with only few studies of dexmedetomidine in spinal anaesthesia. Hence the present study will be undertaken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA physical status I and II.
- •2.Age between 18 to 65 years.
- •3.Patient undergoing surgeries under spinal anaesthesia.
排除标准
- •1.Allergic to the study drugs-bupivacaine and dexmedetomidine 2.A Pre-Operative baseline temperature of more than 37.5 degreeCelsius 3.Patients on long standing opioids 4.Patients suffering from thyroid disorders 5.Patient undergoing surgeries like TURP, where irrigation fluids are used.
结局指标
主要结局
1.To study the efficacy of dexmedetomidine in prevention of shivering in adult patients undergoing surgeries under spinal anaesthesia
时间窗: 10 minutes from Time of Spinal Injection to 180 minutes
次要结局
- To know the side effects of dexmedetomidine(From time of Spinal Injection to 180 minutes)