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临床试验/CTRI/2023/07/055125
CTRI/2023/07/055125尚未招募3 期

Comparison of changes in Serum Cortisol Level During Laryngoscopy And Intubation Using i-view Video Laryngoscope And Machintosh Laryngoscope In Patients Posted For Surgery Under General Anaesthesia.

Department of Anaesthesiology and Critical Care1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the changes in serum cortisol level pre & post intubation using i-view videolaryngoscope & Machintosh laryngoscope.

研究概览

简要总结

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 cause changes in the hormonal level and hemodynamics.

Endotracheal intubation has been demonstrated to impose the most intense stress to humans under general anaesthesia. Triggering the physiologic mechanism off causes local inflammation and hypermetabolic process due to the general substrate mobilization and accelerated biochemical reaction. It is also associated with complex stress response characterized by neuro-humoral, immunological and metabolic alterations. Activation of sympathetic nervous system and increased release of catabolic and immuno-suppressive pituitary hormones can be attributable to surgical stress response. In clinical practice, these activations cause changes in heart rate and blood pressure and alterations in biochemical measurements like  cortisol , noradrenalin, adrenalin, and dopamine levels. The type of surgical procedure, either open or laparoscopic, reflects the severity of traumatic stress imposed to the organism. Open surgery may develop much more stress than laparoscopic surgical procedures due to long surgical time, big surgical incision and local and systemic effects.

Recently the use of videolaryngoscopy has become a widely accepted method in both emergency, routine and clinical anaesthesia. Poor vision at laryngoscopy (grade 3-4) is a relatively common finding (10%) even after excluding patients in whom difficult tracheal intubation was anticipated and an alternative technique was chosen. And in many patients there is a need of more than 3 laryngoscopies (1.9%) and failed direct laryngoscopy may occur though it is a rare event(0.1%). Ease of handling, high success rate in patients with normal and difficult airways and a steep learning curves make these devices very popular among physicians. Video laryngoscopes have now been included among first aid devices for the management of difficult situations by Difficult Airway Society (DAS).

i-viewlaryngoscope is among the latest video laryngoscope in current anaesthetic practice It is distributed by the intersurgical company, providing the option of video laryngoscopy wherever you might need to intubate. i-view is ready to use seconds after removing from packaging.The ergonomic design ensures i-view is easy to use and integrated LCD screen provides an optimal view in variety of light conditions.

In the present study, we therefore intend to compare the changes in S.Cortisol level after laryngoscopy and Intubation using the two devices i.e. i-viewand Macintosh laryngoscope

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
21.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I and II Weight between 40 to 70 kg Patient planned for elective surgery 1,2 MP grades.

排除标准

  • Previous history of multiple/ failed intubation.
  • Predicted difficult laryngoscopy and intubation, MP Grade III and IV.
  • Any pathology of oral cavity that may obstruct the insertion of device.
  • Mouth opening less than 2.5 cm.
  • Potentially full stomach patients (trauma,morbid obesity,pregnancy,history of gastric regurgitation and heart burn) and at risk of esophageal reflux (haitus hernia).

结局指标

主要结局

To compare the changes in serum cortisol level pre & post intubation using i-view videolaryngoscope & Machintosh laryngoscope.

时间窗: The serum cortisol level will be assessed at two point of time one at pre induction and one after the intubation.

次要结局

  • To compare haemodynamic changes( Heart Rate And MAP) after laryngoscopy & intubation(Pre induction)

研究者

发起方
Department of Anaesthesiology and Critical Care
申办方类型
Government medical college

研究点 (1)

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