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临床试验/CTRI/2024/08/072975
CTRI/2024/08/072975尚未招募2 期

Effects on ABG parameters and gastric volume with or without facemask ventilation during induction in patients undergoing laparoscopic surgeries

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare the effect of facemask oxygenation with or without positive pressure ventilation on gastric antral volumes measured by portable ultrasonography

研究概览

简要总结

This study is a prospective, randomized parallel group trial comparing the effect on ABG parameters and gastric volume using ultrasonography with or without facemask ventilation during induction of anaesthesia in patients undergoing laparoscopic surgeries. The study will be conducted in Government Medical College, Amritsar on 60 ASA grade I-II patients of either sex in the age group of 18 to 60 years scheduled for laparoscopic surgery under general anaesthesia, randomly divided into two groups of 30 patients each- Group ’V’ will receive oxygenation via facemask for 3 minutes followed by positive pressure ventilation during apnoea period and Group ’NV’ will receive oxygenation for 3 minutes via facemask and this oxygenation will be continued during apnoea period without positive pressure ventilation. The data thus obtained will be analyzed and compared statistically.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to ASA grade I and II Patients undergoing elective laparoscopic surgeries under general anaesthesia Adequate fasting that is 8 hours for solids and 2 hours for clear fluids BMI less than 30 kg per m2.

排除标准

  • Patient refusal Pregnant or nursing mother Diaphragmatic palsy BMI more than or equal to 30 kg per m2 Patients with history of cardiac or respiratory disease Patients with history of hepatic or renal disease Patients allergic to drugs involved in the study Patients on drugs which affect the gastrointestinal dynamics such as metoclopramide or domperidone or ondansetron or granisetron or atropine Patients with gastroesophageal regurgitation Patients with history of gastrointestinal surgery or trauma.

结局指标

主要结局

To compare the effect of facemask oxygenation with or without positive pressure ventilation on gastric antral volumes measured by portable ultrasonography

时间窗: Time from start of anaesthesia till completion of surgery

To compare the effect of facemask oxygenation with or without positive pressure ventilation on ABG parameters like PaO2 and PaCO2 and pH and HCO3 values

时间窗: Time from start of anaesthesia till completion of surgery

Surgeon satisfaction score

时间窗: Time from start of anaesthesia till completion of surgery

次要结局

  • To compare the risk of gastric content regurgitation and aspiration in patients undergoing facemask oxygenation with positive pressure ventilation and patients receiving facemask oxygenation without positive pressure ventilation(To note any complication related to the procedure)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Veena Chatrath

Government Medical College, Amritsar

研究点 (1)

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