Effect of dexmedetomidine on hemodynamic and recovery responses during tracheal extubation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of dexmedetomidine on hemodynamic and recovery responses during tracheal extubation
研究概览
简要总结
This is a prospective, randomised, double-blinded comparative study to compare the effect of inj. Dexmedetomidine versus normal saline(placebo), both given intravenously over 15 minutes prior to extubation, on hemodynamic parameters and recovery responses during tracheal extubation.
Hemodynamic parameters will be assessed just prior to and after administration of the study drug and then at regular intervals of 5 minutes till 30 minutes in the post operative period.
Extubation parameters(cough responses) will be assessed according to the Extubation Quality Score and undue sedation will be assessed according to Ramsay Sedation Score in the post operative period after 30 minutes.
Any drug related adverse effects will be assessed in the post operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Patients in age group of 18 to 65 years of either sex 2) American Society of Anaesthesiology(ASA) grade I and II 3) Hemodynamically stable patients with all routine investigations within the normal limits.
- •Patients who give informed written consent and are willing to be a part of the study.
排除标准
- •Patients with bleeding disorders or on anticoagulants 2) History of allergy to the drug being used under study 3) Patients unable to comprehend VAS/ known neurological/psychiatric illness 4) ASA III or above 5) Patients with severe cardiovascular or respiratory disorders or difficult airway 6) Patients on medications that affect heart rate (HR) or blood pressure (BP), pregnant, currently breastfeeding women, history of sleep apnea 7) Patients for emergency procedures.
结局指标
主要结局
Effect of dexmedetomidine on hemodynamic and recovery responses during tracheal extubation
时间窗: Hemodynamic parameters will be assesed just prior to administration of study drug. | After giving study drug at 5, 10 and 15 minutes | Post extubation at 3 and 5 minutes. | Post operatively at 0, 5, 10, 15, 20, 25 and 30 minutes.
次要结局
- Effect of Dexmedetomidine on hemodynamic and recovery responses during tracheal extubation(Ramsay Sedation score and Extubation Quality score after extubation)
研究者
Niveditha Kishore Srinivasan
Dr. D.Y. Patil Medical College, Hospital and Research Centre