Comparison between intravenous Midazolam (0.035mg/kg) and intravenous Fentanyl (50mcg) in flexible bronchosopy- A prospective, randomized, double blinded study

Department of Respiratory Medicine, KMC Manipal1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2023年11月24日最近更新: 2023年7月11日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方
入组人数: 72
试验地点: 1
主要终点: Composite score during the bronchoscopy procedure

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To study the effects of intravenous Midazolam (0.035mg/kg) and intravenous Fentanyl (50mcg) on patient response to flexible bronchoscopy.

To assess and compare the patient response and comfort in flexible bronchoscopy done under intravenous Midazolam and intravenous Fentanyl.

To assess and compare the attenuation of pressor response in flexible bronchoscopy done under intravenous Midazolam and intravenous Fentanyl.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator 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

•All patients in the age group 18 to 70 years, weighing 50-85kg and undergoing flexible bronchoscopy in the Department of Respiratory Medicine.

排除标准

•Patients with known or suspected allergy to Midazolam and Fentanyl, patients with Renal impairment, Hepatic impairment, seizure disorder, Psychiatric illness, hemodynamic instability including cardiac failure, second or third degree heart block, heart rate less than 50/ minute, COPD patients with Forced Expiratory Volume less than 50%, Pregnancy and Lactation, Oxygen saturation less than 90%, Platelet count less than 50, 000/ cubic milli meters.

结局指标

主要结局

Composite score during the bronchoscopy procedure

时间窗: at the level of nasopharynx for 1 minute and at the time of passage through trachea for 1 minute

次要结局

1. Ease of Performing bronchoscopy(2. pain and distress measured by Numerical Rating Scale)

研究者

发起方

Department of Respiratory Medicine, KMC Manipal

申办方类型

Other [Deemed Medical College And Hospital]

研究点 (1)

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