Effect of Head Position on MACEI of Sevoflurane in Children With Obstructive Airway (MACEI)
2018年5月10日 更新者：Jingjie Li、Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Effect of Head Position on Minimum Alveolar Concentration of Endotracheal Intubation（MACEI）of Sevoflurane in Children With Obstructive Airway
Children scheduled for tonsillectomy surgery were recruited into the study.
General anesthesia was induced with 8% sevoflurane inhaled with 8 l.min-1 of oxygen via mask, followed by adjustment of inspired sevoflurane to the target concentration based on the result in previous patient at which laryngoscopy and tracheal intubation were attempted and maintained for 12 min.
All responses to tracheal intubation were assessed.
At the end of the procedure, sevoflurane was titrated to the target concentration, which was kept constant for 12 min before a standard stimulus was applied to determine whether the children was awake.
The Dixon's 'up and down'method was used to determine progression of subsequent concentrations.The aim of this study was to determine whether the minimum alveolar concentration of endotracheal intubation（MACEI）of sevoflurane in children with obstructive airway are different from that observed in normal children.
研究概览
详细说明
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
All patients were preoxygenated using 100% oxygen with a normal tidal volumen for 3 min.
The circuit was primed with sevoflurane 8% at a fresh gas flow of 8 Litre/min （L/min） for 1 min.
Anaesthesia was induced with inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.After loss of consciousness, the inspired concentration of sevoflurane was maintained 10-12min a predetermined end-tidal concentration.
A single experienced anaesthetist in the use of endotracheal devices inserted the devices according to the manufacturer's recommendations.
Neuromuscular blocking agents and other intravenous anesthetics were not given.
One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement".
Assesment was made for jaw relaxation and graded with intubation score.
The sum of intubation scores >4 was defined as a failure of insertion.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
If the endotracheal device insertion was successful, sevoflurane concentration for the next patient was decrease by 0.5%.
If not, sevoflurane concentration was increased by the same amount for the next patient.
For their comfort, patients experiencing movement received a 2 mg/kg bolus dose of propofol,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg.If the endotracheal device insertion was successful,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg was also administered.
研究类型
介入性
注册 (预期的)
38
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Shanghai
-
Shanghai、Shanghai、中国
- Shanghai9 Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 至 8年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- class I or II
- children aged 2-8 years
- children with obstruction airway under general anesthesia undergoing tonsillectomy surgery
- signed informed consent
Exclusion Criteria:
- Patients with a history of adverse reactions to sevoflurane
- Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth opening and/or cervical spine disease)
- Patients with reactive airway disease
- Signs of upper respiratory infection
- Violate experimental scheme
- refused to participate
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：30 degree rotated lateral position
19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
|
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
其他名称：
|
|
有源比较器：neutral position
19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in the neutral position.The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
|
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
minimum alveolar anesthetic concentration of endotracheal intubation
大体时间：The sevoflurane concentration is obtained when tracheal intubated immediately.
|
To compare the minimum alveolar anesthetic concentration of endotracheal intubation required for different head position in children with obstructive airway.
|
The sevoflurane concentration is obtained when tracheal intubated immediately.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
intubation score
大体时间：The intubation score is obtained when tracheal intubation was inserted immediately.
|
One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement".
Assesment was made for jaw relaxation and graded with intubation score.
The sum of intubation scores >4 was defined as a failure of insertion.
|
The intubation score is obtained when tracheal intubation was inserted immediately.
|
|
blood pressure include systolic and diastolic in mmHg
大体时间：Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of blood pressure include systolic and diastolic during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
|
heart rate in bpm
大体时间：Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of heart rate during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
|
bispectral index（BIS）, number from 100 (awake) to 40-60(anesthetic status)
大体时间：Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of of bispectral index values during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Li Jing Jie, M.D.、Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Thwaites A, Edmends S, Smith I. Inhalation induction with sevoflurane: a double-blind comparison with propofol. Br J Anaesth. 1997 Apr;78(4):356-61. doi: 10.1093/bja/78.4.356.
- Tanaka S, Tsuchida H, Nakabayashi K, Seki S, Namiki A. The effects of sevoflurane, isoflurane, halothane, and enflurane on hemodynamic responses during an inhaled induction of anesthesia via a mask in humans. Anesth Analg. 1996 Apr;82(4):821-6. doi: 10.1097/00000539-199604000-00025.
- Yasuda N, Lockhart SH, Eger EI 2nd, Weiskopf RB, Liu J, Laster M, Taheri S, Peterson NA. Comparison of kinetics of sevoflurane and isoflurane in humans. Anesth Analg. 1991 Mar;72(3):316-24. doi: 10.1213/00000539-199103000-00007.
- Wajima Z, Inoue T, Yoshikawa T, Imanaga K, Ogawa R. Changes in hemodynamic variables and catecholamine levels after rapid increase in sevoflurane or isoflurane concentration with or without nitrous oxide under endotracheal intubation. J Anesth. 2000;14(4):175-9. doi: 10.1007/s005400070001.
- Goff MJ, Arain SR, Ficke DJ, Uhrich TD, Ebert TJ. Absence of bronchodilation during desflurane anesthesia: a comparison to sevoflurane and thiopental. Anesthesiology. 2000 Aug;93(2):404-8. doi: 10.1097/00000542-200008000-00018.
- Helbo-Hansen S, Ravlo O, Trap-Andersen S. The influence of alfentanil on the intubating conditions after priming with vecuronium. Acta Anaesthesiol Scand. 1988 Jan;32(1):41-4. doi: 10.1111/j.1399-6576.1988.tb02685.x.
- Makkar JK, Ghai B, Bhardwaj N, Wig J. Minimum alveolar concentration of desflurane with fentanyl for laryngeal mask airway removal in anesthetized children. Paediatr Anaesth. 2012 Apr;22(4):335-40. doi: 10.1111/j.1460-9592.2011.03712.x. Epub 2011 Oct 21.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年1月1日
初级完成 (实际的)
2018年1月1日
研究完成 (预期的)
2018年10月31日
研究注册日期
首次提交
2018年4月30日
首先提交符合 QC 标准的
2018年5月10日
首次发布 (实际的)
2018年5月11日
研究记录更新
最后更新发布 (实际的)
2018年5月11日
上次提交的符合 QC 标准的更新
2018年5月10日
最后验证
2018年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2018-15-T15
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.