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临床试验/NCT02017392
NCT02017392Unknown4 期

A Randomized Controlled Study of Compound Lidocaine Cream to Prevent Postoperative Agitation in Patients With Endotracheal Intubation for General Anesthesia

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
2,000
试验地点
1
主要终点
Vital signs like blood pressure and heart rates during extubation.

研究概览

简要总结

The purpose of this study is to determine whether the compound lidocaine cream is effective in preventing postoperative agitation in patients with endotracheal intubation for general anesthesia.

详细描述

This is a randomized controlled study. Some parameters were provided by preliminary test, provided theα=0.05,and β=0.20, the sample size can be estimated to be 2000 by the Open Epi Version 2.Patients will be recruited on the basis of predefined criterias. A researcher will take charge of the recruitment. Participants provide written consent and no financial incentives are provided. They are divided into experimental group and control group randomly. We need to collect their basic information including ages, genders, heights, weights, underlying diseases, surgical procedures and levels classified by ASA. Blood pressure, heart rate and other vital signs during the tube drawing process will be recorded. All the contents needed to be recorded had been compiled into a watch list with detailed instructions for filling in. All the personal information and observation records of participants will be kept in secret and only used for research. Developing standard operating procedure and training all the researchers. A third party will assess the accuracy, completeness and representativeness of registry data. Experimental data will be analysed with the help of statisticians.

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
Single (Participant)

入排标准

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

入选标准

  • aged over 18
  • selective operation patients with endotracheal intubation for general anesthesia

排除标准

  • highly sensitive to local anesthetics of amide derivatives or anything else in compound lidocaine cream
  • congenital or idiopathic methemoglobinemia

研究组 & 干预措施

Compound Lidocaine Cream

Experimental

The cuff of endotracheal tube is covered by 1-2g compound lidocaine cream before the general anesthesia.

干预措施: Compound Lidocaine Cream (Drug)

结局指标

主要结局

Vital signs like blood pressure and heart rates during extubation.

时间窗: an hour

次要结局

  • The cough reflex and breath holding during extubation.(an hour)

研究者

发起方
Third Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanni Wang

student

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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