Evaluation of intravenous magnesium sulphate on haemodynamic responses to laryngoscopy and tracheal intubation in surgeries of ear, nose and throat
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Magnesium sulphate is effective in suppressing the haemodynamic responses to laryngoscopy & tracheal intubation in surgeries of ear, nose & throat.
研究概览
简要总结
The aim of the study is to evaluate the efficacy of intravenous magnesium sulphate on haemodynamic responses during laryngoscopy and tracheal intubation. The objective is to also observe the incidence and severity of adverse effects of intravenous magnesium sulphate. Magnesium sulphate will be administered over a period of 1 minute prior to induction along with general anaesthesia. During laryngoscopy , patient’s haemodynamic parameters will be recorded non invasively at prescribed time intervals.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 随机化方法
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- Weight between 40-65 kg, either gender , ASA physical status I and II, patients undergoing elective ENT surgery.
排除标准
- Patient refusal , emergency surgery.
- History of cardiovascular , pulmonary, renal , hepatic , endocrinal or neurological disease.
- Preoperative hypotension , patients on antipsychotics.
- Patient on digitalis , calcium channel blockers and alpha & beta agonist or antagonist .
- Sinus bradycardia, heart blocks, conduction defects.
- Obesity, pregnancy , lactation, anticipated difficult airway, allergy to study drugs.
- Any change needed in the technique of anesthesia or duration of laryngoscopy for >30 seconds.
结局指标
主要结局
Magnesium sulphate is effective in suppressing the haemodynamic responses to laryngoscopy & tracheal intubation in surgeries of ear, nose & throat.
时间窗: Until 5 minutes after laryngoscopy
次要结局
- To observe the incidence & severity of adverse effects of intravenous magnesium sulphate, if any.(Until 5 minutes after laryngoscopy)
研究者
研究点 (1)
标识符
- CTRI 编号
- CTRI/2023/08/055967
日期
- 最近更新
- (3年前)
监管与共享
- 个体参与者数据共享计划
- 是
Will individual participant data (IPD) be shared publicly (including data dictionaries)? Response - YES What data in particular will be shared? Response - All of the individual participant data collected during the trial, after de-identification. What additional supporting information will be shared? Response - Study Protocol Response - Informed Consent Form Who will be able to view these files? Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. For what types of analyses will this data be available? Response - To achieve aims in the approved proposal. By what mechanism will data be made available? Response (Others) - will be decided later For how long will this data be available start date provided 31-12-2024 and end date provided 31-12-2029 ? Response - Beginning 3 months and ending 5 years following article publication. Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - nil