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临床试验/CTRI/2025/08/093079
CTRI/2025/08/093079尚未招募不适用

Randomised comparative study between atomised intranasal dexmedetomidine , lignocaine and ketamine as premedication for flexible fibreoptic bronchoscopy

ESIC MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月1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
60
试验地点
1
主要终点
patient cough score

研究概览

简要总结

the study aims to compare the effectiveness of  atomised intranasal demedetomedine, lignocaine and ketamine as premedication for flexible fibreoptic bronchoscopy. Primary objective is to evaluate the incidence of moderate to severe cough during the procedure. Secondary objective is to compare the patient satisfaction score, endoscopist satisfaction score, ramsay sedation score and if any rescue lignocaine required. ASA I & II patients of more than 18 years age with BMI less than 30 kg/m2 will be included and patients with history of bronchial asthma or allergy to the study drugs will be excluded. 60 patients will be randomly divided into 3 groups of 20 each. atomised ketamine (2mg/kg), atomised dexmedetomidine (2 mcg/kg) and atomised lignocaine (1.5 mg/kg) will be given as premedication 30 inutes prior to the procedure and the above mentioned objectives will be assessed. P values less than 0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • ASA I & II patients, age older than 18 years, BMI less than 30 kg/cm2.

排除标准

  • ASA III & IV patients, history of bronchial asthma, history of allergy to the study drugs.

结局指标

主要结局

patient cough score

时间窗: baseline,immediately after passage of bronchoscope through vocal cords, at 5 and 10 minutes during the bronchoscopy procedure

次要结局

  • patient satisfaction score(10 minutes after end of procedure)
  • ramsay sedation score(prior to procedure, 10 minutes after end of proceure)
  • endoscopists satisfaction score(after end of procedure)
  • rescue lignocaine required(during procedure)

研究者

发起方
ESIC MEDICAL COLLEGE AND HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Prerna Bhola

ESIC MEDICAL COLLEGE

研究点 (1)

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