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临床试验/NCT01345747
NCT01345747已完成不适用

The Laryngeal Tube Suction vs Endotracheal Tube for Ventilation in Gynecological Laparoscopic Surgery

Prince of Songkla University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
respiratory parameter

研究概览

简要总结

This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective gynecological laparoscopic surgery.

详细描述

Background:

For standard procedure, the endotracheal tube is used to ventilate the anesthetized patients who undergo gynecological laparoscopic surgery that increase intrabdominal pressure. Now there is a new supraglottic airway device, laryngeal tube suction (LTs) can be use instead of ETT.

Objective This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective gynecological laparoscopic surgery.

Material and methods Prospective single blinded randomized control trial, the patients were divided into two groups, LTs group and ETT group n = 60 for each group. All patients were induced anesthesia with fentanyl 1-2 mcg/kg, propofol 2 mg/kg, vecuronium 0.1 mg/kg then maintained anesthesia with air : oxygen 30%. Respirator setting are tidal volume 10 ml/kg, I/E 1:2 adjust RR base on ETCO2 keep ETCO2 35-40 mmHg.

Results No statistical difference in demographic data between groups. PAP and ETCO2 in the LTs group were significant higher than ETT group in the first 5 and 10 minutes but no statistically significant after 10 minutes until the end of operation. No statistically significant in TV and SpO2 between groups. In ETT group MAP and HR after insertion are significant higher than LTs group, no statistically significant about postoperative complication such as sorethroat, hoarseness and nausea vomiting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female age between 20-65 years
  • ASA class 1-2
  • elective gynecologic laparoscopic surgery
  • height < 180 cm
  • BMI < 35 kg/m2

排除标准

  • interincisor gap < 2.5 cm
  • risk of aspiration
  • history of difficult intubation
  • oropharyngeal pathology
  • allergy to anesthetic drug

结局指标

主要结局

respiratory parameter

时间窗: 1-3 hours

ETCO2, peak airway pressure and expired TV during operative period

次要结局

  • hemodynamic response(30 minutes)

研究者

申办方类型
Other

研究点 (2)

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