NCT01724970Unknown3 期
A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.
University of Padova2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- oropharyngeal leak pressure
研究概览
简要总结
Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.
详细描述
The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class I-III
- •candidates to bariatric surgery
排除标准
- •uncontrolled psychiatric symptomatology
- •known or presumed pregnancy
- •history of surgery on the airway or esophagus
- •gastroesophageal reflux
结局指标
主要结局
oropharyngeal leak pressure
时间窗: intraoperatively, up to 3 hours
次要结局
- total anesthetic and analgesic drug dosages(intraoperatively and postoperatively, up to 24 hours from end of surgery)
- satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)(day 1)
- satisfaction of the surgeon (ad hoc questionnaire)(day 1)
- total dosage of analgesic and antihemetic drugs(intra and postoperatively up to 24 hours)
- time to post-anesthetic discharge scoring system (PADSS) > 8(in PACU up 72 hours)
- EKG monitoring(postoperatively up to 72 hours)
- gastric distension(intraoperatively up to 3 hours)
- levels of pain and nausea (Visual Analogue Scale)(postoperatively up to 24 hours)
- pulse oximetry saturation(intraoperatively and postoperatively, up to 24 hours from end of surgery)
- metilen's blue(before end of surgery up to 3 hours)
研究者
研究点 (2)
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