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临床试验/NCT05550051
NCT05550051已完成不适用

Lignocaine Nebulization Versus Airway Block for Awake Nasal Fiberoptic Intubation in Patients With Head and Neck Burns. A Randomized Controlled Study.

Ain Shams University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Time to performing awake nasal fiberoptic intubation

研究概览

简要总结

This study evaluates the efficacy and ease of lignocaine nebulization to deliver anesthesia to the upper airway of patients with head and neck burns undergoing reconstructive surgery in need of awake nasal fiberoptic intubation compared to the traditional upper airway nerve block.

详细描述

Adequate preparation for Awake Fiberoptic Intubation (AFOI) is an art of anesthesia which includes, many methods such as blocking nerves supplying the upper airway including the superior laryngeal, recurrent laryngeal, and glossopharyngeal nerves. Topical anesthesia via a special cannula as you proceed, and lignocaine nebulization. Succeeding in blocking the airway adequately is the first step towards a successful AFOI.

Although many studies have been done to compare the topical anesthesia technique versus the airway block techniques but theses studies have ignored the fact that in many cases of difficult airway indicated for AFOI there is limited or even absent neck mobility, and mouth opening both which are mandatory to perform an adequate airway neural block.

After anesthetizing the airway in both groups either by nebulization or airway block, an anesthesiologist who will be blinded to the study groups will perform the (AFOI) by using an endotracheal tube size 7.5 mm internal diameter endotracheal tube for males and 7 mm for female patients.

Vital signs such as HR, BP, and oxygen saturation (SpO2) will be recorded recorded immediately after intubation and 5 min postintubation and at every 10 minutes during surgery.

The patient response, and satisfaction with the technique will be recorded by using the revised non verbal pain scale (NVPS-R).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • All patients above 18 years with ASA classification II, III, and no known hypersensitivity for local anesthetics

排除标准

  • Patient refusal
  • Patients under 18 years
  • Patients suffering from coagulopathies or bleeding tendencies
  • Patients with ASA 4 classification
  • Non cooperative patients
  • Patients undergoing extensive facial reconstruction
  • Patients with known hypersensitivity to lignocaine.

结局指标

主要结局

Time to performing awake nasal fiberoptic intubation

时间窗: 5 minutes

Will be measured by calculating the time to awake nasal fiberoptic intubation

Patient comfort during performing awake nasal fiberoptic intubation

时间窗: 5 minutes

Will be measured by the revised non verbal pain sale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameh Refaat

Principal investigator

Ain Shams University

研究点 (2)

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