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临床试验/NCT05253404
NCT05253404已完成不适用

Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Study

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Hemodynamic

研究概览

简要总结

Stabilizing hemodynamic and reducing pulmonary complications during extubation with switching endotracheal tube to laryngeal mask in craniotomies

详细描述

recruit ASA: 1-3, 20-65 years old undergoing neurosurgery under general anesthesia Excluded 1.Decline to participated 2.Difficult airway 3.Body Mass Index >30 4. Pregnant woman 5.Nothing Per Os <8hrs(case number:80).

General anesthesia Induction: 0.15-0.2 mg/kg cisatracurium or 0.6-1.2mg rocuronium , 1.5-2 mg/kg propofol, 1-2 mcg/kg Fentanyl. Endotracheal tube 6.5-7.5mm. Maintenance with sevoflurane 2- 3% FiO2:100%. Optimal muscle tension monitor. When surgery done, sevoflurane at 2.63-2.97%

Then randomly assigned two group Anesthesia group(control group) : Removed endotracheal tube at sevoflurane at 2-3% Switching group (intervention group): Intervention with endotracheal tube to laryngeal mask, and removing laryngeal mask at sevoflurane: 0.4MAC

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participant will going general anesthesia

入排标准

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

入选标准

  • ASA: 1-3, 20-65 years old undergoing craniotomies under general anesthesia

排除标准

  • Decline to participated
  • Difficult airway
  • Body Mass Index >30
  • Pregnant woman
  • Nothing Per Os <8hrs

结局指标

主要结局

Hemodynamic

时间窗: 30 minutes

Blood pressure including systolic, diastolic and mean arterial pressure and heart rate during extubation

Pulmonary complications

时间窗: 24 hours

Rate of Participants with Cough, Bucking, Laryngospasm, Aspiration, Desaturation(SpO2%\< 90%) and Need airway assist device(Nasal or oral airway)

Partial pressure of carbon dioxide in arterial blood

时间窗: 20 mins

Partial pressure of carbon dioxide in arterial blood five minutes before and after extubation

次要结局

  • Re-do surgery(24 hours)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei. Cheng-Fong

Principal Investigator

Chang Gung Memorial Hospital

研究点 (2)

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