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临床试验/NCT06374017
NCT06374017已完成4 期

Evaluating the Effect of Topical Lidocaine Spray Versus Dexmedetomidine Spray on Suppression of Stress Response to Laryngoscopy and Endotracheal Intubation: a Randomized Controlled Study

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
To measure systolic blood pressure immediately after intubation.

研究概览

简要总结

Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs ,

详细描述

This study will be conducted in the operating theatres of Cairo university hospitals.

Patients undergoing any surgery under general anesthesia and needs endotracheal intubation using direct laryngoscopy will be assigned to one of the three groups:

Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation Group L: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation Group D: : will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • ASA I,II
  • Age 18-60y
  • Patients scheduled for any operations under general anesthesia and needs endotracheal intubation using direct laryngoscopy in the operating theatre.

排除标准

  • • Uncontrolled high blood pressure > 160/100 heart disease in the form of ischemic heart disease and severe valvular disease.
  • Patients with the history of allergy to lidocaine or dexmedetomidine.
  • ASA III & IV.
  • Patients refuse to share in this study
  • Suspected difficult intubation that needs more than 2 trials.

研究组 & 干预措施

Group C

Placebo Comparator

Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation

干预措施: Normal saline, Lidocaine, dexmetomidine (Drug)

Group L

Active Comparator

: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation

干预措施: Normal saline, Lidocaine, dexmetomidine (Drug)

Group D

Active Comparator

will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.

干预措施: Normal saline, Lidocaine, dexmetomidine (Drug)

结局指标

主要结局

To measure systolic blood pressure immediately after intubation.

时间窗: Immediately after endotracheal intubation

Using invasive blood pressure monitoring

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Mahmoud Mohamed

Lecturer of Anesthesia and Surgical ICU and pain management

Kasr El Aini Hospital

研究点 (1)

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