The effect of pre-operative dexmedetomidine nebulisation on pulmonary haemodynamics during laryngoscopy and intubation in cardiac surgery patients: A prospective randomised control trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Compare change in pulmonary artery systolic pressure (PASP) and mean pulmonary artery pressures (mPAP) during laryngoscopy and intubation.
研究概览
简要总结
Laryngoscopy and intubation both produce stress response by increasing heart rate, blood pressure, pulmonary artery pressures.
The effect of dexmedetomidine to reduce systemic haemodynamic response during laryngoscopy and intubation is demonstrated in cardiac and non cardiac patients.
Inhalational route has been found to have less systemic effects such as hypotension and bradycardia than intravenous route.
Whether the reduction in pulmonary haemodynamic response during induction is significant or not has not been studied much.
Hypotheses is nebulised dexmedetomidine is more effective in preventing increase in pulmonary artery pressures compared to placebo during laryngoscopy and intubation in cardiac surgery patients.
Primary objective is to compare change in pulmonary artery pressure parameters (pulmonary artery systolic pressure and mean pulmonary artery pressures) during laryngoscopy and intubation between patients receiving dexmedetomidine and placebo nebulisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Inclusion Criteria
- •Age 18-55 years
- •Both genders
- •Elective cardiac surgery
- •Mitral valve repair or replacement
- •Mitral stenosis, mitral regurgitation
- •Coronary artery bypass graft with mitral valve replacement.
排除标准
- •EXCLUSION CRITERIA
- •Anticipated difficult airway.
- •Preoperative heart rate < 50 bpm
- •Uncontrolled AF and ventricular rate
- •Second degree heart block and bundle branch blocks
- •Right atrial mass or thrombus
- •Emergency surgery.
结局指标
主要结局
Compare change in pulmonary artery systolic pressure (PASP) and mean pulmonary artery pressures (mPAP) during laryngoscopy and intubation.
时间窗: Within 2 successful intubation attempts
次要结局
- Compare PASP and systolic blood pressure (SBP) ratio (PASP/SBP) during laryngoscopy and intubation(every 1 minute of induction of anesthesia till 15 minutes following intubation)
- Compare PASP, PADP, mPAP, PVR, SBP, DBP, MAP, systemic vascular resistance, cardiac output (CO) and cardiac index (CI)(every 1 minute of induction of anesthesia till 15 minutes following intubation)
- Compare change in pulmonary vascular resistance (PVR)during laryngoscopes and intubation(every 1 minute of induction of anesthesia till 15 minutes following intubation)
- Compare dose of propofol and fentanyl required during intubation response to optimise blood pressure(every 1 minute of induction of anesthesia till 15 minutes following intubation)
- Compare dose of inotropes or vasopressors required(every 1 minute of induction of anesthesia till 15 minutes following intubation)