Comparative Study About The Effect Of Dexmedetomidine Vs Lignocaine On Hemodynamic Stability During Tracheal Extubation, Especially In Resource Limited Populations
2026年6月11日 更新者:Adeel Ahmed、Mayo Hospital Lahore
Comparative Study About The Effect Of Dexmedetomidine Vs Lignocaine On Hemodynamic Stability During Tracheal Extubation, Especially In Resource Limited Populations: A Randomized Controlled Trial
This randomized, double-blind controlled trial aims to compare the effectiveness of intravenous dexmedetomidine (0.5 µg/kg) and lignocaine (1.5 mg/kg) in attenuating hemodynamic responses during tracheal extubation in adult patients undergoing elective surgery.
Tracheal extubation is commonly associated with sympathetic stimulation, leading to tachycardia, hypertension, and airway reflex responses, which may increase perioperative risk.
A total of 60 ASA I patients aged 18-50 years will be randomly allocated in a 1:1 ratio; one receiving dexmedetomidine and the other lignocaine, administered intravenously 10 minutes prior to extubation.
A structured proforma will be used to record hemodynamic parameters, including heart rate, systolic and diastolic blood pressure, and mean arterial pressure at baseline, before extubation, during extubation, and at 1, 3, 5, and 10 minutes post-extubation.
The primary objective is to evaluate and compare the ability of these agents to attenuate hemodynamic responses during extubation.
The findings of this study are expected to help identify a safe and effective strategy for smoother extubation and improved hemodynamic stability, particularly in resource-limited healthcare settings.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Murva Javid
- 电话号码:+923313232475
- 邮箱:murvajavid@gmail.com
学习地点
-
-
Punjab Province
-
Lahore、Punjab Province、巴基斯坦、54000
- Mayo Hospital Lahore
-
接触:
- Murva Javid
- 电话号码:+923313232475
- 邮箱:murvajavid@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 60 adult patients, aged between 18 and 50 years. •ASA I patients, undergoing elective procedures, requiring general anaesthesia and intubation. •Normotensive patients ( systolic BP<140 mm Hg and diastolic BP <90 mm Hg) before surgery.
Exclusion Criteria:
- Patients with known hypersensitivity to dexmedetomidine or lignocaine. •Pregnant or breastfeeding women. •Emergency cases. •Patients with anticipated difficult airway. • History of hypertension or cardiac arrhythmias.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Group A (Dexmedetomidine)
|
Effect of Dexmedetomidine on hemodynamic responses during tracheal extubation.
Effect of Lignocaine on hemodynamic responses during tracheal extubation.
|
|
有源比较器:Group B (Lignocaine)
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Effect of Dexmedetomidine on hemodynamic responses during tracheal extubation.
Effect of Lignocaine on hemodynamic responses during tracheal extubation.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparison of mean arterial pressure (MAP) during tracheal extubation
大体时间:[Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
|
Mean arterial pressure (MAP) measured at baseline, after drug administration, 1 minute post- extubation, 3 minutes post-extubation, 5 minutes post-extubation and 10 minutes post-extubation, comparing the effect of dexmedetomidine 0.5 microgram/kg versus lignocaine 1.5 mg/kg.
|
[Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Heart rate response during tracheal extubation
大体时间:[Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
|
Comparison of changes in heart rate (beats per minute) between the dexmedetomidine and lignocaine groups at baseline (T0), before extubation (T1), during extubation (T2), and at 1, 3, 5, and 10 minutes after extubation (T3-T6).
The outcome will be expressed as mean heart rate and mean change from baseline at each time point.
|
[Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Murva Javid、Mayo Hospital Lahore
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年6月11日
首先提交符合 QC 标准的
2026年6月11日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月11日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- Mayo3
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.