CTRI/2018/04/013011招募中1/2 期
Evaluation of intratracheal lignocaine as compared to normal saline to reduce emergence reactions in the patients undergoing endoscopic transphenoidal pituitary surgery : a double blind randomized controlled trial
All India Institute of Medical Sciences AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年9月2日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To determine the effect of intratracheal lidocaine on suppressing the cough on emergence from general anesthesia in patients undergoing endoscopic transphenoidal pituitary surgery.
研究概览
简要总结
In this study we will be instilling 2% lignocaine 0.05ml in group L and Normal saline 0.05ml in group NS , 5 minutes before extubation in patients who underwent endoscopic transphenoidal surgery.This type of study have never been done in endoscopic trans sphenoidal surgery patients. We will be determinining the effect of lignocaine in suppressing the cough during emergence from anaesthesia. Preventing cough in this patients is important in these patients to prevent the increase in intracranial pressure post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 18 – 65 years of age.
- •ASA grade I & II patients.
- •Patients of Pituitary tumor posted for elective endoscopic transphenoidal surgery for tumor excision.
排除标准
- •Refusal of consent
- •Patients with history of smoking or chronic cough
- •Patients with history of upper respiratory tract infection (URI) in last 8 weeks
- •Patients with bleeding disorders
- •Previous laryngeal or tracheal surgery or pathology
- •Patients with history of gastric reflux
- •Patients with pulmonary disease, renal, cardiac or hepatic disorders, uncontrolled diabetes
- •Patients with clinical sign of hypothyroidism
- •Patients with BMI > 35kg/mt2
- •Patients with the history of hypertension (controlled or uncontrolled)
- •Patients with upper respiratory tract infection
- •Patients having history of allergic reactions to study drug Post inclusion exclusion :
- •Need of more than 2 attempts of tracheal intubation or need of bougie for tracheal intubation
- •Patients who can not be extubated and are planned for elective ventilation.
结局指标
主要结局
To determine the effect of intratracheal lidocaine on suppressing the cough on emergence from general anesthesia in patients undergoing endoscopic transphenoidal pituitary surgery.
时间窗: During emergence from general anesthesia after the end of the surgery
次要结局
- To determine effect of intratracheal lignocaine on HR and BP changes(To determine the effect of intratracheal lignocaine on the emergence time, extubation time and recovery time)
研究者
研究点 (1)
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