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临床试验/CTRI/2025/07/091302
CTRI/2025/07/091302尚未招募2/3 期

Comparison of face mask ventilation before and after neuromuscular blockade in patients under general anaesthesia

Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年7月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
125
试验地点
1
主要终点
Expiratory tidal volume

研究概览

简要总结

This study aims to compare face mask ventilation before and after giving a muscle relaxant in adult patients under general anaesthesia. All patients will be assessed before surgery with a medical history clinical examination and relevant investigations. Demographic data such as age ,sex, height ,weight and American Society of Anaesthesiologiats status will be recorded. Patients who are pregnant under 18 years old ,have a Body Mass Index over 30 or have anticipated difficulty with face mask ventilation will be excluded.

In the operating room standard monitoring including Electrocardiogram,Non invasive blood pressure and Saturation prbe will be applied and patients will be positioned supine with their head in a sniffing position. Premedication with intravenous Midazolam 1 milligram and Fentanyl 2 microgram per kilogtam will be administered. After preoxygenation anaesthesia will be induced with intravenous Propofol 2 milligram per kg .Face mask ventilation will be performed using a standard technique and ventilator settings of inspiratory pressure 10 centimeter of water, Positive end expiratory pressure of 5 centimeter of water, Inspiratory to Expiratory ratio 1 to 2 ,gas flow 6 litres per minute .respiratory rate 12 per minute and Sevoflurane 2 to 3 percent in 100 percent oxygen. Expired tidal volumes and Han scale grading for face mask ventilation will be recorded

One minute later intravenous Vecuronium 0.1 milligram per kg will be administered and face mask ventilation will be reassessed at 1minute ,2 minute, 3minute and 4 minutes after its administration. The primary objective is to evaluate changes in face mask ventilation before and after the neuromuscular blockade.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Elective surgical procedure under general anaesthesia.

排除标准

  • Pregnant females
  • Patients with BMI more than 30 kg per meter square
  • Anticipated difficult face mask ventilation.

结局指标

主要结局

Expiratory tidal volume

时间窗: Expiratory tidal volume before and after neuromuscular blockade at 1minute,2 minute,3 minute and 4 minutes

次要结局

  • Han scale grade of face mask ventilation(Han scale grade of face mask ventilation before and after neuromuscular blockade at baseline)

研究者

发起方
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nurya Gupta

ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi

研究点 (1)

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