A comparative study of two infusion doses of Dexmedetomidine for alleviating stress response to tracheal extubation in patients undergoing laparoscopic cholecystectomy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- - Haemodynamic changes during tracheal extubation
研究概览
简要总结
This is a prospective randomized double blinded study designed to compare two infusion doses of Dexmedetomidine for evaluating haemodynamic response and airway response during tracheal extubation.
Total of 60 patients undergoing laparoscopic cholecystectomy who fulfil the inclusion criteria and who have given written informed consent will be randomly assigned into 2 groups.
Each group of 30 patients will receive different infusion doses of Dexmedetomidine.
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Group D0.3 will receive Inj. Dexmedetomidine 0.3 μg/kg/hour IV infusion.
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Group D0.5 will receive Inj. Dexmedetomidine 0.5 μg/kg/hour IV infusion.
Effect of both the doses of the drug will be monitored in terms of sympathetic responses during tracheal extubation like heart rate and mean arterial pressure. Laryngeal reflexes and cough response will be monitored using 5-point scale.
This study aims to optimise the extubation process and enhance patient safety. Overall, this study holds significant potential to improve the management of endotracheal extubation, which is a critical step in the postoperative care of patients. By minimizing the cardiovascular and airway responses associated with extubation, Dexmedetomidine could contribute to enhanced patient outcomes and reduce the risk of life-threatening complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •ASA Grade I & II patients undergoing Laparoscopic Cholecystectomy.
排除标准
- •Those on β-blockers, Digoxin, Alpha 2-adrenergic agonists or psychotropic medications.
- •Patients with Heart Rate below 60 per min or Blood Pressure less than 100 mmHg systolic and less than 60 mmHg diastolic.
- •Patients with a history of allergic reactions to drug used in study.
- •Patients who required postoperative mechanical ventilation.
- •Pregnant or nursing woman.
- •Morbidly obese patients.
- •ASA Grade III & IV patients.
- •Anticipated difficult intubation.
结局指标
主要结局
- Haemodynamic changes during tracheal extubation
时间窗: During extubation
- Airway response using 5 point scale during tracheal extubation
时间窗: During extubation
次要结局
- - Time taken for emergence & tracheal extubation(- Evaluation for presence of complications such as laryngospasm, bronchospasm, delayed recovery, respiratory depression, & bradycardia)
研究者
Dr. Janvi Vikram Thakkar
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital