Comparative assessment of I-gel and LMA Proseal for airway management in controlled hypertensive patients posted for short surgical procedures.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insertion time (in secs)
研究概览
简要总结
This study will mainly focus on comparing i-gel with LMA proseal regarding their airway management and pressor response in controlled hypertensive patients. Ethical clearance has been taken for this prospective,randomised, single blinded comparative trial that will be conducted in the Anaesthesiology dept of North Bengal Medical College and Hospital. Sixty patients of either sex, aged 20-60yrs, MPG I-II, controlled hypertensive will be included in the study after proper counselling and obtaining informed consent. Patients with anticipated difficult airway, risk of aspiration, recent history of sore throat and lung co-morbidity will be excluded from the study. Randomisation will be done by computer generated code in sequentially numbered sealed envelope. Study variables will include insertion time as primary outcome and others like number of insertion attempts, ease of insertion, fibre-optic grading of larynx, oro-pharyngeal leak pressure, hemodynamic responses (mean arterial pressure/ heart rate) before and after 1 min, 2min, 3min, and 5min post insertion of supraglottic airway device. Post-operative blood staining , sore-throat and dysphagia will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.MPG I&II 2.Mouth opening >2.5cm 3.Controlled hypertensives (BP≤140/90mm of Hg with medication).
排除标准
- •1.Restricted mouth opening (≤2.5cm) 2.Risks of aspiration( GERD, hiatus hernia) 3.Oropharyngeal pathology, cervical spine fracture or instability 4.History of known or anticipated difficult airway.
结局指标
主要结局
Insertion time (in secs)
时间窗: Time recorded from which the predetermined sized lubricated SAD was picked up to the time it was correctly placed with first effective end-tidal capnography waveform was seen
次要结局
- Number of attempts for insertion
- Ease of insertion(Easy/Difficult)
- Fibreoptic assessment of airway tube on a four point scale(Brimacombe scoreïƒ 4:only vocal cords are visible, 3: cords and posterior epiglottis visible, 2: cords and anterior epiglottis visible, 1: vocal cords not seen)
- Hemodynamic responses(MAP/HR)
- Oropharyngeal leak pressure(cm of H2O)
- Post-operative complications(Airway trauma)
