A Randomized Comparative Study of Fentanyl 2 mcg/kg versus 4 mcg/kg in Attenuating the Hemodynamic Stress Response during Laryngoscopy and Endotracheal Intubation in Patients undergoing Intracranial Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean systolic BP
研究概览
简要总结
Laryngoscopy and tracheal intubation are known to cause significant sympathetic stimulation, resulting in transient increases in heart rate and blood pressure. These hemodynamic responses can be particularly dangerous in patients undergoing intracranial surgery due to the risk of elevated intracranial pressure and compromised cerebral perfusion. Fentanyl, a potent opioid analgesic, is commonly used to blunt these responses.
This study aims to compare the efficacy of two different fentanyl dosing regimens—2 mcg/kg versus 4 mcg/kg—in attenuating the hemodynamic changes associated with direct laryngoscopy and intubation in patients undergoing intracranial surgery. The primary outcomes include changes in heart rate, systolic and diastolic blood pressure, and mean arterial pressure during and after laryngoscopy. The study also evaluates the safety profile of each dose in this sensitive patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA physical status class 1 and 2 posted for elective intracranial surgery Patient who will give informed written consent Body weight 40 to 70 kg range.
排除标准
- •Patients having severe systemic illness and bleeding disorders, Pregnant and lactating female Patients allergic to study drugs Anticipated difficult airways.
结局指标
主要结局
Mean systolic BP
时间窗: 0 MIKN 2 MIN 4 MIN 6 MIN 8 MIN 10 MIN 15 MIN
Mean diastolic BP
时间窗: 0 MIKN 2 MIN 4 MIN 6 MIN 8 MIN 10 MIN 15 MIN
Mean of mean BP
时间窗: 0 MIKN 2 MIN 4 MIN 6 MIN 8 MIN 10 MIN 15 MIN
Mean heart rate
时间窗: 0 MIKN 2 MIN 4 MIN 6 MIN 8 MIN 10 MIN 15 MIN
Proportion of cases having adverse effects if any in both the groups
时间窗: 0 MIKN 2 MIN 4 MIN 6 MIN 8 MIN 10 MIN 15 MIN
次要结局
- To assess and compare the proportion of patients developing intraoperative complications (hypotension, bradycardia tachycardia chest rigidity)(To assess and compare total dose of Propofol in mg required for induction of anaesthesia in both the groups)
