A Comparative evaluation of biochemical markers to stress response after intubation using Macintosh Laryngoscope, C-Mac Video Laryngoscope & Fiberoptic Bronchoscope: A Prospective Randomized study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To compare changes in serum cortisol level post intubation compared to pre induction using Direct Laryngoscope, Video Laryngoscope and Fiberoptic Bronchoscope.
研究概览
简要总结
It is a Prospective Randomized study to do a comparative evaluation of biochemical markers to stress response after intubation using Macintosh Laryngoscope, C-Mac Video Laryngoscope & Fiberoptic Bronchoscope. Direct Laryngoscopy and endotracheal intubation are considered among the most invasive stimuli of the practice of general anaesthesia which leads to stimulation of pharyngeal and tracheolaryngeal nociceptors resulting in hemodynamic stress response. Laryngoscopy and intubation constitutes to be an important component of General Anaesthesia. These have proven to be life saving in many circumstances. However they can also causes changes in the hormonal level and hemodynamics. Endotracheal intubation has been demonstrated to impose the most intense stress to humans under general anaesthesia. As there is less studies available at present, this study will help to evaluate biochemical markers and hemodynamic changes of stress response after intubation. In our study we are going to compare three different intubation techniques Macintosh laryngoscope, a rigid video laryngoscope and fiberoptic technology to observe stress response.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients planned for elective surgery under general anaesthesia in JN Medical College and Hospital in time period between 2023-25, ASA Grade I & II, BMI 18-25Kg/sq.m, MP Grades 1 & 2.
排除标准
- •Previous history of multiple/ failed intubation, Predicted difficult laryngoscopy and intubation in MP equal to or more than 3 grade, Any pathology of the oral cavity that may obstruct the insertion of device, Mouth opening less than 2.5cm, Patient with any endocrine disorder or on any such concerned medications, Potentially full stomach patients like trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn and at risk of esophageal reflux like hiatus hernia.
结局指标
主要结局
To compare changes in serum cortisol level post intubation compared to pre induction using Direct Laryngoscope, Video Laryngoscope and Fiberoptic Bronchoscope.
时间窗: First baseline sample of Serum Cortisol will be taken during pre induction time and then second sample will be taken after 5 minutes of intubation, comparing three devices Direct Laryngoscope, Video Laryngoscope and Fiberoptic Bronchoscope.
次要结局
- To compare changes in serum prolactin, high sensitivity C reactive protein level post intubation compared to pre induction using the three devices(First baseline sample of Serum prolactin, high sensitivity C reactive protein level will be taken during pre induction time & then second sample will be taken after 5 minutes of intubation, comparing three devices Direct Laryngoscope, Video Laryngoscope & Fiberoptic Bronchoscope.)
- To compare haemodynamic changes.(To compare haemodynamic changes post intubation compared to pre induction after 1,3, & 5 minutes of intubation.)
- To compare the time required for intubation.(To compare the time required for intubation using the three devices in seconds)
- To compare the number of attempts required for intubation(To compare the number of attempts required for intubation)
- To compare the success rate of intubation(To compare the success rate of intubation)
- To compare the number of adjustment maneuvers required for successful intubation.(To compare the number of adjustment maneuvers required for successful intubation.)
研究者
Nishant Varshney
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh