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临床试验/NCT02429323
NCT02429323已完成不适用

Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients: Incremental Versus High Concentration Inhalation Induction

University of Sulaimani0 个研究点目标入组 100 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
induction to intubation time in seconds

研究概览

简要总结

Aim of the study is to compare the optimal time needed for successful tracheal intubation with immediate 8% sevoflurane and incremental sevoflurane induction in surgical pediatric patients undergoing adenotonsillectomy without using muscle relaxants or opioids

详细描述

Investigators studied 100 pediatric surgical patients admitted to Sulaimani Teaching Hospital in the Otorhinolaryngology, Head and Neck Surgical Department, from the first of June 2011 to the first of September 2011, Children aged 2-7 years,both genders, ASA physical statuses І and II (ASA I: a healthy normal patient, while ASA II: a patient with mild systemic disease with no functional limitations) were scheduled for elective adenotonsillectomy operations. They were randomly divided into two equal groups according to the induction method.

Group 1 (G1) using incremental induction with sevoflurane (1-8 %) in 100% O2, the vapor concentration is increased by 1% every few breaths.

Group 2 (G2) high concentration of sevoflurane (8%) in 100% O2 from the beginning of induction.

None of them is given premedication or any other adjunct drugs until successful intubation is done; ventilation was assisted and then controlled when possible. If upper airway obstruction occurred, an oropharyngeal airway was immediately inserted. Attempts were made to obtain venous access before laryngoscopy. All patients monitored with electrocardiography (ECG), noninvasive blood pressure monitoring (NIBP), pulse oximetry, and temperature measurements.

Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed were excluded from this study.

研究设计

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

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 2-7 years old American society of anesthesiologists physical status class 1 and 2 scheduled for elective adenotonsillectomy operations

排除标准

  • Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed

研究组 & 干预措施

sevoflurane concentration 8%

Active Comparator

sevoflurane concentration 8% from the start

干预措施: Sevoflurane (Drug)

incremental sevoflurane (1-8%)

Active Comparator

incremental increase of the concentration each few breaths from 1% to 8%

干预措施: Sevoflurane (Drug)

结局指标

主要结局

induction to intubation time in seconds

时间窗: during the surgery

effect of high concentration of sevoflurane on shortening the induction to intubation time

次要结局

未报告次要终点

研究者

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

Amir M. Boujan

Senior Anesthesiologist

University of Sulaimani

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