Comparison of Baska® Mask versus I-gel for minor surgical procedures under general anaesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- KIMS
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- First time success rate %
研究概览
简要总结
Abstract
Background
Minor surgicalprocedures under general anaesthesia requires a patent airway without the useof muscle relaxant. supraglottic airway devices have been used widely forairway management. A study was undertaken to compare first time insertionsuccess rate, insertion time, sealing pressure and complications of Baska®Mask with I-gel.
Methods
After approval from theinstitutional ethical committee ,a randomized single blinded study was conducted on 50 American Society ofAnesthesiologists’physical status I and II female patients aged between 18-40years who underwent minor surgical procedures ( duration < 60 minutes) under general anaesthesia. Patients were randomized into two groups of25 each, by sealed envelope technique. (group B-Baska® Mask ; groupI-I-gel). All patients were monitoredusing non-invasive blood pressure (NIBP), electrocardiogram (ECG), pulseoximetry and capnography. The first time success rate, mean insertion time andsealing pressure were measured.
Results
The first time successrate of Baska® Mask was 21/24(88%) when compared to I-gel which was 23/25 (92%) p 0.585. The insertion time of Baska®Mask was 14.9±6.2 s and that of I-gelwas 14.7±4.4 s. (p 0.877) The meansealing pressure of Baska® Mask was significantly higher when compared to the I-gel (28.9±3.5 vs 25.9±2.5 cm H2O) p 0.001
Baska® Maskhas a first time success rate, insertion time which is comparable with I-gel.The sealing pressure of Baska®Mask was significantly more than I-gel.Both the devices had complications which were comparable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •American Society of Anesthesiologists’physical status I and II who underwent minor surgical procedures ( duration < 60 minutes) under general anaesthesia.
- •Patients who underwent elective surgical procedures with fasting period of 6 hours and Mallampati I,II or III.
排除标准
- •Patients with neck pathology, anticipated difficult airway, pregnant women, increased risk of aspiration, mouth opening <2.5 cm, body mass index >30 kg.m-2.
结局指标
主要结局
First time success rate %
时间窗: successful placement of the device
次要结局
- Time of insertion of the device(Sealing pressure)