EVALUATION OF EFFECT OF NEBULISED DEXMEDETOMIDINE ON ATTENUATING THE HEMODYNAMIC RESPONSE TO INTUBATION DURING ENTROPY TARGETED ANAESTHESIA
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hemodynamic (heart rate, Blood pressure) response to laryngoscopy and tracheal intubation
研究概览
简要总结
Laryngoscopy and intubation are painful stimuli and can cause unpredictable, transient, and variable haemodynamic changes. This response happens within 30 seconds after intubation and lasts for about 10 min. The consequences of laryngoscopy and intubation can include precipitation of ischaemia, cerebrovascular stroke, increase in intracranial pressure, arrhythmias, pulmonary oedema in the vulnerable patients. The efficacy of dexmedetomidine in reducing the response to laryngoscopy and tracheal intubation will be evaluated during this study.
Dexmedetomidine is a selective alpha 2 adrenoceptor agonist. It has analgesic, hypnotic, sedative, anxiolytic, , sympatholytic, and anti-sialagogue properties and promotes cardiac, respiratory, and, neurological stability. Dexmedetomidine has the potential to cause unwanted side effects like bradycardia and hypotension when administered as an intravenous bolus.
Dexmedetomidine has additional benefit of reducing the dose of anaesthetic used, which will also be evaluated during this study. The anaesthetic sparing effect of dexmedetomidine has been studied via the intravenous route in various studies.
This study aims to evaluate the effectiveness and safety of nebulised dexmedetomidine premedication in attenuating the haemodynamic stress response during laryngoscopy and tracheal intubation. The propofol sparing effect of dexmedetomidine and its effect on postoperative sore throat will also be studied during induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Patients of ASA 1 and 2 undergoing general surgery under general anaesthesia requiring tracheal intubation.
排除标准
- •patients with body mass index more than 35 kg per meter square 2) patients with increased risk of aspiration of gastric contents 3) patients with airway difficulty score more than 8 4) patients with upper respiratory tract infection 5) patients with hepatic or renal insufficiency 6) patients with history of smoking or exposure to household smoke 7) patients taking medications which affect heart rate or blood pressure 8) pregnant patients.
结局指标
主要结局
Hemodynamic (heart rate, Blood pressure) response to laryngoscopy and tracheal intubation
时间窗: Hemodynamic (heart rate, Blood pressure) before nebulization (baseline), after nebulization, immediately after intubation, 1 minute after intubation, 5 minutes after intubation, 10 minutes after intubation, and at the end of surgery.
次要结局
- The dose requirement of propofol for induction of anaesthesia to achieve target entropy(prior to and during induction of anaesthesia)
- incidence of postoperative sore throat.(at the end of surgery and 30 minutes after the end of surgery)
研究者
Shivangi Sharma
MM Institute of Medical Science and Research, Mullana, Ambala