跳至主要内容
临床试验/CTRI/2025/05/087274
CTRI/2025/05/087274尚未招募不适用

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

SMS MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月6日最近更新:

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)

研究者

发起方
SMS MEDICAL COLLEGE AND HOSPITAL
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验