A prospective randomised double blinded study to compare efficacy of two different doses of dexmedetomidine for attenuation of pressor responses to laryngoscopy and endotracheal intubation under bispectral index- controlled general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary outcome of our study will be to assess haemodynamic changes (HR, SBP, DBP, MAP) from baseline upto 30 min after intubation.
研究概览
简要总结
The aim of our study is to compare attenuation of the pressor responses to laryngoscopy and endotracheal intubation with two varying doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) under bispectral index- controlled general anaesthesia in patients undergoing various elective surgeries under general anaesthesia in terms of :-
PRIMARY OBJECTIVES :
Haemodynamic changes (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure)
SECONDARY OBJECTIVES :
Sedation score (RSS) before and after dexmedetomidine infusion
Dose requirement of induction agent (Propofol)
Complications/side effects, if any
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 18 and 55 years.
- •Body weight 50 to 70 kg.
- •Patients belonging to ASA (American Society of Anaesthesiologists) physical status class-I and II.
- •Patients undergoing elective surgeries under general anaesthesia.
排除标准
- •Patient’s refusal.
- •Uncooperative patients.
- •Any known hypersensitivity or contraindication to Dexmedetomidine.
- •History of convulsion, bleeding disorder, severe neurological deficit, thyroid disorder.
- •Patient with history of respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above).
- •Patients having a history of significant neurological, psychiatric, or neuromuscular disorders.
结局指标
主要结局
The primary outcome of our study will be to assess haemodynamic changes (HR, SBP, DBP, MAP) from baseline upto 30 min after intubation.
时间窗: Duration of study is around 1 year
次要结局
- secondary outcome will be assessment of sedation of patient using Ramsay Sedation Score (RSS) pre-operatively i.e before infusion with Dexmeditomidine and after completion of infusion. Intraoperative DOSAGE REQUIREMENT OF PROPOFOL for induction will also be noted in our study and the effect of two varying doses of dexmedetomidine on intraoperative DOSAGE REQUIREMENT OF PROPOFOL will be assessed.(Any associated SIDE EFFECTS/COMPLICATIONS)