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临床试验/NCT02655380
NCT02655380已完成4 期

Remifentanil Requirement for Acceptable Intubating Condition With Two Dose Ketamine Without Neuromuscular Blocking Agent in Children

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年6月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
acceptability of intubation condition

研究概览

简要总结

Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Therefore, the combination use of ketamine and remifentanil could be useful for acceptable intubating condition in the general anesthesia without the use of neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2 mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine induction dose for intubation without neuromuscular blocking agent. The investigators focus on remifentanil dose using Dixon's up and down method.

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
Double (Participant, Investigator)

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Undergoing general anesthesia with endotracheal tube

排除标准

  • Anticipated difficult airway
  • Patient with upper respiratory infection within 14 days

研究组 & 干预措施

ketamine 1

Experimental

Anesthesia induction with ketamine 1 mg followed by remifentanil.

干预措施: Ketamine 1 (Drug)

ketamine 1

Experimental

Anesthesia induction with ketamine 1 mg followed by remifentanil.

干预措施: Remifentanil (Drug)

ketamine 2

Experimental

Anesthesia induction with ketamine 2 mg followed by remifentanil.

干预措施: Ketamine 2 (Drug)

ketamine 2

Experimental

Anesthesia induction with ketamine 2 mg followed by remifentanil.

干预措施: Remifentanil (Drug)

结局指标

主要结局

acceptability of intubation condition

时间窗: during and after intubation, about 2 minute

For assessment of intubation condition, 5 variables will be individually evaluated though 3 point scale (excellent, good, poor). If all variables are graded as excellent, intubation condition will be excellent. If at least 1 variable is poor, it will be reported as poor. Otherwise, it will be reported as good. Good and excellent will be considered to be acceptable intubating condition. Poor will be reported as unacceptable intubating condition. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing

次要结局

未报告次要终点

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

yun jeong chae

Associate Professor

Ajou University School of Medicine

研究点 (1)

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