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临床试验/CTRI/2020/01/022910
CTRI/2020/01/022910尚未招募1 期

Efficiency of Face Mask Ventilation before and after Neuromuscular Blockade : A Randomised Control Trial

Indira Gandhi Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月24日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
120
试验地点
1
主要终点
The primary outcome will be the average of mask expiratory tidal volume measured at 30,60,90 seconds after apnea onset. The secondary outcome will be the time from apnea to tracheal intubation

研究概览

简要总结

A very important aspectof inducing a patient under general anaesthesia is securing an airway forintraoperative ventilation. Expert airway management is an essential skill inanaesthetic practice for allowing oxygenation, ventilation and anaesthetic gasdelivery.[1] Tracheal intubation remains the most common approach to airwaymanagement.

The general sequence ofinduction of anaesthesia is administration of an analgesic and IV anaestheticagent after which facemask ventilation is tested and lastly a neuromuscular blockingagent is administered. Because of possible development of airway catastrophes,muscle relaxants have long been recommended to be administered after confirmingadequate face mask ventilation, without any scientific validation of thisprincipal.

The rationale fordelaying administration of muscle relaxant is the belief that if face maskventilation in an anaesthetised non-paralysed patient is ineffective, thepatient can be reversed and an alternative airway management can be considered.Life threatening hypoxemia can therefore, theoretically, be averted.[2]

In 2008, Calder and Yentis argued against thepractice of checking facemask ventilation. They questioned the validity andsafety of this practice. The argument against the practice was that ifneuromuscular blocking agent is delayed on the pretext of assessing facemaskventilation, the anaesthetist has already lightened the plane of anaesthesiafor the said patient and caused difficult ventilation. [4]

If facemask ventilationis difficult or impossible in an anaesthetised non-paralysed patient there aretwo courses of action that may be followed. First course could be to withholdall anaesthetic agents and allow the plane of anaesthesia to become superficialcausing the spontaneous return of respiration. The second approach is toadminister a neuromuscular blocking agent (Suxamethonium or rocuronium) tofacilitate intubation and ventilate the patient, but, if even intubation fails,patient can be reversed and spontaneous respiration awaited. Both approachesseem logical as long as spontaneous respiration is achieved before severehypoxemia develops. The limitation here, however, is that the pre-existinganatomic problems which were causing difficult facemask ventilation in thefirst place have been worsened with administration of anaesthetic agents whichled to collapse of the upper airways. Therefore, the chances of achievingspontaneous respiration in an apnoeic, anaesthetised patient before severe hypoxemiadevelops is minute. [4]

At this crossroads the rationale of the practice of delayedadministration of neuromuscular blocking agent becomes questionable.

  Investigatorshave reported either no effect or improvements in mask ventilation difficultyscores and exhaled volumes after neuromuscular blocking drugs have beenadministered.

This study uses cis-atracuriumas the non-depolarising neuromuscular blocking agent. It is four to five times as potent as atracurium and does not causehistamine release. It provides intubating conditions in a dose of 0.10 -0.15mg/kg within 2 minutes and results in blockade of intermediate duration.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients of ASA physical status 1 and 2 2 Patient with airway of Mallampati Grade I and II.
  • 3 Patient willing to participate.

排除标准

  • Exclusion criteria : 1 Patient’s refusal to participate.
  • 2 Patients with pregnancy, morbid obesity, full stomach and emergency surgery.
  • 3 Patients with ASA Physical status III and above.
  • 4 Patient with suspected difficult airway and Mallampatti Grade III and IV.
  • 5 Patients with known predictors of difficult airway such as BMI>35 kg/m2, history of neck mass/ irradiation, cervical trauma, restricted neck movement, OSA, limitation in mouth opening or jaw protrusion 6 Patients with allergy to study drug, neuromuscular disorders.

结局指标

主要结局

The primary outcome will be the average of mask expiratory tidal volume measured at 30,60,90 seconds after apnea onset. The secondary outcome will be the time from apnea to tracheal intubation

时间窗: 30,60,90 seconds after apnea onset.

次要结局

  • The secondary outcome will be the time from apnea to tracheal intubation(onset of apnea to tracheal intubation)

研究者

申办方类型
Government medical college

研究点 (1)

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