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临床试验/NCT06601036
NCT06601036招募中不适用

Sevoflurane Sedation as an Alternative for Awake Fiberoptic Intubation in Difficult Airway Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Degree of patient satisfaction

研究概览

简要总结

The aim of this study is to compare patient satisfaction and intubating conditions with fiber optic intubation under sevoflurane sedation versus airway blocks in difficult airway patients

详细描述

Awake fiberoptic intubation (AFOI) is a suitable option for anticipated difficult intubation. The ideal condition for AFOI requires a calm, cooperative patient with blunted airway reflexes to facilitate easy intubation, especially if there is difficulty with laryngeal anatomy and/or pathology.

For this purpose, sedative and anxiolytic agents such as benzodiazepines, sevoflurane, remifentanil, ketamine, propofol, and dexmedetomidine are almost always required to relieve the patients from comfort without impairing ventilation. Patient responsiveness and cooperation are almost always required.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 50 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Patients with difficult airway (Mallampati grade 3 and 4 with mouth opening less than 5 cm).

排除标准

  • Patient refusal.
  • Patients with bleeding disorders and nasal mass.
  • Allergy or intolerance to one of the study medications.
  • Patients with uncontrolled systemic diseases.
  • patients with gastro-esophageal reflex.
  • history of nasopharyngeal surgery or drug abuse.

研究组 & 干预措施

Sevoflurane sedation group

Experimental

Patients will undergo fiberoptic intubation under sevoflurane sedation.

干预措施: Sevoflurane (Drug)

Awake fiberoptic group

Active Comparator

Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block.

干预措施: 2% Xylocaine (2 ml ) (Drug)

结局指标

主要结局

Degree of patient satisfaction

时间窗: Immediately after intubation

The degree of patient satisfaction will be assessed on a 4-point Likert scale patient satisfaction (1, very dissatisfied; 2, unsatisfied; 3, satisfied; 4, very satisfied).

次要结局

  • Intubation time(Intraoperatively)
  • Heart rate(5 minutes after intubation)
  • Mean arterial pressure(5 minutes after intubation)
  • Patient's tolerance to endoscopy(Intraoperatively)
  • Patient's tolerance to intubation(Intraoperatively)

研究者

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

Marwa Ahmed Abogabal

Lecturer of Anesthesiology, Intensive Care and Pain, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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