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临床试验/CTRI/2025/04/085320
CTRI/2025/04/085320尚未招募不适用

Evaluation of lignocaine nebulization with intravenous lignocaine in attenuation of pressor response to laryngoscopy and endotracheal intubation

Gandhi Medical College and Associated hospitals1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年5月5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
70
试验地点
1
主要终点
Mean heart rate

研究概览

简要总结

The major responsibility of an anaesthesiologist is to secure airway to provide adequate ventilation to the patient during general anaesthesia. Endotracheal intubation is the gold standard of securing the airway.  Laryngoscopy and endotracheal intubation is associated with intense sympatho-adrenal stimulation resulting in increase in heart rate (HR) and blood pressure (BP) consequent to the release of catecholamines . The cardiovascular response is a reflex phenomenon. Intravenous lignocaine has been used to suppress cough during tracheal intubation,laryngospasm and cough during extubation . It has also been used to suppress airway hyperactivity and mitigate bronchoconstriction . Intravenous lignocaine with its well established centrally depressant and anti-arrhythmic effects is found to be more suitable alternative to attenuate the stress response as compared to other forms of lignocaine.

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
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to give written informed consent Patients undergoing elective surgery requiring general anaesthesia Patients of either sex ASA Grade I & II Patients having MPG I &II Not allergic to study drug.

排除标准

  • Patient refusal Patients with anticipated difficult intubation Patients with HTN COPD IHD and arrhythmia History of allergy or contraindication to to study drugs Pre existing hypotension (systolic blood pressure less than 90 mmHg) Pre existing bradycardia (heart rate less than 60 beats per minute) Current use of medications affecting blood pressure or heart rate ( beta-blockers calcium channel blockers) History of gastroesophageal reflux disease (GERD) or significant oral or pharyngeal pathology ASA grade III IV V Pregnancy or breastfeeding Psychiatric patients Patients with hepatic and renal dysfunction More than 1 attempt of intubation or more than 30 seconds intubation time.

结局指标

主要结局

Mean heart rate

时间窗: Baseline vitals | T1-one minute post intubation & laryngoscopy | T3-Three minute post intubation & laryngoscopy | T5-Five minute post intubation & laryngoscopy | T7-Seven minute post intubation & laryngoscopy | T10-Ten minute post intubation & laryngoscopy

Mean systolic blood pressure

时间窗: Baseline vitals | T1-one minute post intubation & laryngoscopy | T3-Three minute post intubation & laryngoscopy | T5-Five minute post intubation & laryngoscopy | T7-Seven minute post intubation & laryngoscopy | T10-Ten minute post intubation & laryngoscopy

Mean Diastolic blood pressure

时间窗: Baseline vitals | T1-one minute post intubation & laryngoscopy | T3-Three minute post intubation & laryngoscopy | T5-Five minute post intubation & laryngoscopy | T7-Seven minute post intubation & laryngoscopy | T10-Ten minute post intubation & laryngoscopy

MAP (mean arterial pressure)

时间窗: Baseline vitals | T1-one minute post intubation & laryngoscopy | T3-Three minute post intubation & laryngoscopy | T5-Five minute post intubation & laryngoscopy | T7-Seven minute post intubation & laryngoscopy | T10-Ten minute post intubation & laryngoscopy

次要结局

  • Proportion of cases with side effects(10 minutes post intubation)

研究者

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

Dr Anjali soni

Gandhi medical college and Associated Hamidia hospitals Bhopal M.P

研究点 (1)

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