Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Tolerability of propofol for supragloqtic airway devices insertion
研究概览
简要总结
to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™.
to determine the hemodynamic changes during insertion of supraglottic devices in patients undergoing elective surgery and any complications after device insertion.
详细描述
The investigators enrolled ASA physical status I-III patients who were 18-70 years old and scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.), reactive airway disease, signs of respiratory infection or a plan to remain intubated were excluded from the study. The investigators also excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index > 35 kg/m2).
Patients were randomized into 4 groups (I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™ SGAs) according to a computer generated randomization list and patients were allocated consecutively. The sample size of each group required 10 patients.
All patients were pre-oxygenated with 100% oxygen. After the administration of 2 µg/ml intravenous fentanyl for 5 minutes, anesthesia was induced with the Schnider pharmacokinetic TCI system. After equilibration of the plasma-site and effect-site concentrations in propofol TCI, 1 of the 4 types of SGA was randomly inserted by two anesthesiologists (resident trainee and staff doctor) who were unaware of the actual plasma concentration of propofol without the use of a muscle relaxant.
The response of each patient determined the effect-site concentration of propofol of the next patient. "No Response" was defined as Laryngeal Mask Airway Insertion Score = 0 and "Response" was defined as Laryngeal Mask Airway Insertion Score ≥ 1. If the insertion of the supraglottic airway device was successful ("No Response"), then the target effect-site concentration was decreased by a step of 0.4 µg/ml. If the insertion failed ("Response"), the target effect-site concentration was increased by the same dose. The patients' responses to LMA insertion was classified by blinded investigators.
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, Investigator)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III patients.
- •Patients 18-70 years old .
- •Patients scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.
排除标准
- •Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.).
- •Adults with reactive airway disease.
- •Adults with signs of respiratory infection or a plan to remain intubated were excluded from the study.
- •Excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index > 35 kg/m2).
研究组 & 干预措施
Group SP
The Supreme™ group
干预措施: Propofol Fresenius (Drug)
Group PS
The ProSeal™ group
干预措施: Propofol Fresenius (Drug)
Group IG
The I-gel™ group
干预措施: Propofol Fresenius (Drug)
Group LT
The Laryngeal Tube Suction IITM group
干预措施: Propofol Fresenius (Drug)
结局指标
主要结局
Tolerability of propofol for supragloqtic airway devices insertion
时间窗: 2 years
The effect-site concentration of propofol required to insert supraglottic airway devices.
次要结局
- Blood pressure changes from baseline after insertion of supraglottic devices(2 years)
研究者
Nalinee Kovitwanawong
Assistant Professor
Prince of Songkla University
