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临床试验/CTRI/2025/08/092336
CTRI/2025/08/092336尚未招募4 期

Effect of nebulization with lignocaine, dexmedetomidine and lignocaine with dexmedetomidine on degree of ease of fiber-optic intubation.

Gandhi Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate the ease and success rate of fibreoptic

研究概览

简要总结

After obtaining approval from Ethic Committee of our Institute, this observational study will be performed on 60 ASA I-II adult patients of either gender, aged 18-60, scheduled for elective surgeries under general anaesthesia will be chosen after obtaining their consent to participate in this study.  Standard anaesthesia monitoring will be established (ECG, NIBP, CAPNOGRAPHY, HR, SPO2), IV access with 18G IV canula will be secured. The patients will be divided into three groups as per the discretion of the anaesthesiologist and patient’s clinical condition as Group D, Group L, Group DL to receive nebulization with 4% lignocaine 5ml, dexmedetomidine 2mcg/kg, 4% lignocaine 5ml + dexmedetomidine 2mcg/kg respectively. Glycopyrrolate 0.2mg IM will be given 30 minutes before surgery and two drops of 0.1% Xylometazoline will be instilled in both the nostrils. Patients will be nebulized for 20 minutes before intubation along with oxygenation with nasal prongs at a flowrate of 4L/min. Adequate local anaesthesia will be confirmed by heaviness of the tongue and dryness of posterior pharynx of patients. During fibreoptic intubation, 2ml lignocaine 4% will be administered by spray-as-you-go technique. Fibreoptic intubation will be performed by using flexible fibreoptic bronchoscope preloaded with 7.5mm/7.0mm ET tubes for males and females respectively. ET tube position will be confirmed by auscultation and capnography. Grading system will be used for assessing intubating conditions, vocal cord positions, cough severity, comfort during intubation and post intubation assessment. Intubation time is defined as the time from passing the fibreoptic endoscope tip through the nostril to the first reading obtained by capnography after endotracheal intubation. Continuous monitoring of vitals will be done at baseline, after nebulization and post intubation at 1, 3, 5, 15 minutes. Sedation level will be assessed after nebulisation just before procedure with Ramsay Sedation score. Patients will be induced with standard GA protocol.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of ASA Grade.
  • I , II Age group 18-60 years of either sex All patients scheduled to undergo elective surgery in the supine position under general anaesthesia.

排除标准

  • Thrombocytopenia or coagulopathy Nasal polyp, nasal obstruction and h/o previous nasal surgeries Non-cooperative patients Pregnant females Patients allergic to study drug.

结局指标

主要结局

To evaluate the ease and success rate of fibreoptic

时间窗: Study starts 30 minutes prior to fibreoptic intubation till 15 minutes post intubation

intubation after nebulisation using lignocaine with

时间窗: Study starts 30 minutes prior to fibreoptic intubation till 15 minutes post intubation

dexmedetomidine, lignocaine alone and

时间窗: Study starts 30 minutes prior to fibreoptic intubation till 15 minutes post intubation

dexmedetomidine alone.

时间窗: Study starts 30 minutes prior to fibreoptic intubation till 15 minutes post intubation

次要结局

  • To observe the hemodynamic parameters in three groups.(The hemodynamic parameters recorded are heart rate, O2 saturation, systolic & diastolic blood pressure. These parameters will be recorded at baseline, after nebulization for 20 minutes & at 1 minute, 3 minutes, 5 minutes & 15 minutes post intubation.)

研究者

发起方
Gandhi Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Haresh S

Gandhi Medical College

研究点 (1)

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