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临床试验/NCT04664595
NCT04664595已完成不适用

Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

Prince of Songkla University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
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

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

Sham Comparator

The Supreme™ group

干预措施: Propofol Fresenius (Drug)

Group PS

Active Comparator

The ProSeal™ group

干预措施: Propofol Fresenius (Drug)

Group IG

Active Comparator

The I-gel™ group

干预措施: Propofol Fresenius (Drug)

Group LT

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nalinee Kovitwanawong

Assistant Professor

Prince of Songkla University

研究点 (2)

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