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临床试验/CTRI/2024/08/072996
CTRI/2024/08/072996尚未招募2 期

Additive effect of nitroglycerine spray with lignocaine spray lignocaine spray alone on haemodynamic responses to laryngoscopy and endotracheal intubation a comparative study

King Georges Medical University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年9月13日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
124
试验地点
1
主要终点
To measure and compare the effect of Nitroglycerine 400ug with lignocaine (15%) 2 puff and Lignocaine (15%) 2 puff alone on the hemodynamic responses to laryngoscopy and endotracheal intubation.

研究概览

简要总结

This prospective randomized controlled study is comparing the effects of Nitroglycerine 400ug with lignocaine (15%) 2 puff and Lignocaine (15%) 2 puff alone on the hemodynamic responses to laryngoscopy and endotracheal intubation. A total 124 patients will be enrolled as per inclusion-exclusion criteria. Patients will be divided randomly into two groups of 62 each. In group N, Nitroglycerine 400ug with lignocaine (15%) 2 puff will be sprayed and in group L, Lignocaine (15%) 2 puff will be sprayed before laryngoscopy and tracheal intubation. During surgery, the patient’s pulse rate, blood pressure, ECG, urine output, and blood loss will be monitored continuously. After the intubation, at intervals of 1, 3, 5, 10, and 15 minutes after laryngoscopy and tracheal intubation, the vital parameters will be monitored. Adverse effects will be noted for both groups separately and compared.

研究设计

研究类型
Interventional
分配方式
Randomized
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 who were classified as ASA grade I/II, had ages ranging between 18 to 60 years, were scheduled for elective surgeries under general anesthesia with endotracheal intubation, and provided written informed consent will be included in the study.

排除标准

  • Patients who exhibited allergy to the study drug, anticipated difficult airways, required emergency surgical procedures, possessed a history of laryngeal or tracheal surgery or any related pathology, had pre-existing cardiac disease, hypertension, or chronic obstructive pulmonary disease (COPD), or refused to provide consent will be excluded from participation in the study.

结局指标

主要结局

To measure and compare the effect of Nitroglycerine 400ug with lignocaine (15%) 2 puff and Lignocaine (15%) 2 puff alone on the hemodynamic responses to laryngoscopy and endotracheal intubation.

时间窗: • At intervals of 1, 3, 5, 10, and 15 minutes after laryngoscopy and tracheal intubation, the vital parameters will be monitored and compared.

次要结局

  • To compare the adverse effect of the Nitroglycerine 400ug with lignocaine (15%) 2 puff & Lignocaine (15%) 2 puff alone on the hemodynamic responses to laryngoscopy & endotracheal intubation.(During & after laryngoscopy & tracheal intubation (Approximately 30 min))

研究者

发起方
King Georges Medical University
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Vasioullah Khan

King Georges Medical University

研究点 (1)

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