CTRI/2025/10/095513招募中2/3 期
Effect of intranasal Dexmedetomidine on hemodynamic responses during tracheal extubation in hypertensive patients undergoing laparoscopic cholecystectomy: A Randomized Controlled Trial
All India Institute Of Medical Sciences ,New Delhi1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年10月10日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in mean blood pressure from baseline at the time of extubation
研究概览
简要总结
| Endotracheal extubation causes transient hemodynamic changes leading to increase in blood pressure and heart rate (HR) due to increase in sympathoadrenergic activity caused by epipharyngeal and laryngopharyngeal stimulation. Hypertensive patients undergoing surgical procedures like laparoscopic cholecystectomy are at amplified risk for adverse hemodynamic events during peri extubation period, making them ideal candidates for evaluating the efficacy of a sedative-sympatholytic agent like intranasal dexmedetomidine. While previous research has explored the intravenous use of dexmedetomidine to modulate extubation responses, literature on the intranasal route, particularly in hypertensive patients, remains sparse. This study is required to investigate the effectiveness of intranasal dexmedetomidine in attenuating hemodynamic responses during tracheal extubation in hypertensive patients undergoing laparoscopic cholecystectomy. By evaluating the efficacy and safety of intranasal dexmedetomidine, this study can inform clinical practice, optimize perioperative care, and potentially improve patient outcomes. The findings of this study can contribute to the development of evidence-based guidelines for managing hypertensive patients undergoing laparoscopic cholecystectomy, ultimately enhancing patient safety and reducing morbidity. |
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with controlled hypertension on anti hypertensive medications.
- •Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
- •Patients falling under ASA- II,III category.
排除标准
- •Patients allergic to dexmedetomidine.
- •Patients having severe cardiac conduction abnormalities.
- •Patients on chronic sedatives or opioid use.
- •Patients having nasal pathology preventing intranasal drug delivery
- •Patients with heart rate less than 60 beats per minute.
结局指标
主要结局
Changes in mean blood pressure from baseline at the time of extubation
时间窗: 0, 1, 2, 3, 5, 10,15 minutes after extubation
次要结局
- Visual Analogue Scale (VAS) pain score(15, 30, 60 minutes after extubation)
- Changes in heart rate(HR), systolic blood pressure(SBP) and diastolic blood pressure( DBP) from baseline at the time and after extubation(0, 1, 2, 3, 5, 10,15 minutes after extubation)
- Sedation Score (Ramsay Sedation Score)(15, 30, 60 minutes after extubation)
- Incidence of adverse events ( for example bradycardia, hypotension, nausea, vomiting, delayed emergence)(2 hours post operatively)
研究者
Kartik Saini
All India Institute of Medical Sciences, New Delhi
研究点 (1)
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