DETERMINATION OF THE EFFICACY OF LOW DOSE INTRAVENOUS DEXMEDETOMIDINE FOR PREVENTION OF SHIVERING IN PARTURIENTS UNDERGOING UNDER SPINAL ANAESTHESIA: RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- decreased incidence of shivering after spinal anaesthesia intraoperatively
研究概览
简要总结
Shivering after spinal anaesthesia is a common complication. This leads to redistribution of central heat to the periphery and overall heat loss. Shivering increases oxygen consumption, metabolic rate, carbon dioxide production, lactic acidosis. Also it interferes with electrocardiography, blood pressure, oxygen saturation
monitoring and has its detrimental effects on wound healing and coagulation. Dexmedetomidine being a alpha-2 adrenergic receptor agonist, due to its peripheral and central anti -shivering effects , even at a lower dose it can be a useful drug to perioperative shivering in caesarean section patients and it has lesser side effects compared to traditional anti shivering agents
Aim :
low dose intravenous administration of dexmedetomidine and placebo (normal saline) in prevention of shivering during spinal anesthesia for lower segment caesarean section patients
Objectives:
-
To compare the incidence of shivering among dexmedetomidine and placebo groups
-
To evaluate the effect of dexmedetomidine on
Severity of shivering
Body temperature
Hypotension
hemodynamic parameters
Materials and Methods :A Prospective Double blinded Randomised Controlled Trial
Sample size: 36 in each group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients with uncomplicated term singleton pregnancy undergoing elective caesarean delivery.
- •Parturients belonging ot American society of Anaesthesiologists classification I.
- •Age 18-35 years.
- •Parturients giving informed writen and valid consent.
排除标准
- •Parturients having hypertensive disorders of pregnancy and diabetes mellitus.
- •Parturients having BMI>40kg/m
- •Parturients having pre-existing hypo or hyperthermia before operation.
- •Parturients having hypersensitivity to any of the drugs.
- •Parturients with cardiac, cerebrovascular , renal and liver disorders.
结局指标
主要结局
decreased incidence of shivering after spinal anaesthesia intraoperatively
时间窗: The outcomes will be assessed every five minutes till the end of surgery | baseline,5th minute, 10th minute, | 15th minute,20th minute,25th minute,30th minute
次要结局
- 1. Decreased change in core body temperature intraoperatively and postoperatively(2. Decreased incidence of hypotension intraoperatively, nausea and vomiting postoperatively)
研究者
DR V Nivedha
karnataka institute of medical science