NCT03614598已完成不适用
Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 546 人开始时间: 2009年4月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 546
- 试验地点
- 2
- 主要终点
- Incidence of pharyngolaryngeal postoperative pain of the three devices
研究概览
简要总结
The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •Adult patients > 18
- •ASA score I-III
- •Patient scheduled to undergo elective surgery lasting less than two hours under general anaesthetic without tracheal intubation
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant or breastfeeding
- •Emergency surgery
- •Sore thoat ≤ 1 month
- •Risk of aspiration of gastric contents
- •Body mass index (BMI) > 35
- •Patients with expected airway difficulties
- •Contra-indication for any of the devices (symptomatic hiatal hernias, pathological obesity, poly trauma or serious injury, delayed gastric emptying, use of opiates during fasting)
- •Patients who are not fasting for routine and emergency anesthesia
- •Trismus, limited mouth opening, abscess or pharyngoperilaryngeal mass
排除标准
- 未提供
研究组 & 干预措施
I-GEL®
Active Comparator
干预措施: Insertion of I-GEL(R) device (Procedure)
LMA-UNIQUE™
Active Comparator
干预措施: Insertion of LMA-UNIQUE(TM) device (Procedure)
LMA-SUPREME™
Active Comparator
干预措施: Insertion of LMA-SUPREME(TM) device (Procedure)
结局指标
主要结局
Incidence of pharyngolaryngeal postoperative pain of the three devices
时间窗: 24 hours
Sore throat Y/N
次要结局
- Time taken to place device(End of surgery (maximum 2 hours))
- Necessity of altering the size of the device(End of surgery (maximum 2 hours))
- Total leakage pressure of the devices(End of surgery (maximum 2 hours))
- Device stability during surgery(End of surgery (maximum 2 hours))
- Any patient movement during procedure(End of surgery (maximum 2 hours))
- Ventilatory pressure of the devices(End of surgery (maximum 2 hours))
- Pharyngolaryngeal postoperative pain between groups(2 hours)
- Number of attempts needed to place device(End of surgery (maximum 2 hours))
- Difficulty of insertion(End of surgery (maximum 2 hours))
- Difficulty of device removal(End of surgery (maximum 2 hours))
研究者
研究点 (2)
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