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临床试验/CTRI/2024/05/067114
CTRI/2024/05/067114已完成2/3 期

Comparison of face mask ventilation efficiency before and after neuromuscular blockade: Double blinded randomised control study

Sri Ramachandra Medical College and Research Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Vte at 30, 60, 90, 120, 150 and 180s for a total of 180s of face mask ventilation after cessation of response using mechanical ventilator.

研究概览

简要总结

Face mask ventilation is essential for general anaesthesia and rescue oxygenation in terms of airway management. The estimated incidence of difficult face mask ventilation is 1%–1.5%. There are methods to improve face mask ventilation, of which neuromuscular blocking drugs (NMBDs) are also reported. But in practice, a NMBD is generally given only after confirmation of satisfactory facemask ventilation. This study hypothesizes that a NMBD will improve face mask ventilation in a patient with a normal airway.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of either gender aged 18-65 years of ASA I and II posted for elective surgery under general anaesthesia.

排除标准

  • Anticipated difficult airway Patient refusal Allergy to the study drug.

结局指标

主要结局

Vte at 30, 60, 90, 120, 150 and 180s for a total of 180s of face mask ventilation after cessation of response using mechanical ventilator.

时间窗: At 30, 60, 90, 120, 150 and 180 seconds

次要结局

  • Han’s grading for face mask ventilation(During apneic ventilation)
  • Intubation time(From laryngoscopy to appreance of first capnography wave)
  • Ease of laryngoscopy (vocal cord movement, limb movement, and coughing)(Throughtout intubation)

研究者

发起方
Sri Ramachandra Medical College and Research Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Varun Kumar S

Sri Ramachandra Medical College and Research Hospital

研究点 (1)

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