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临床试验/NCT04467424
NCT04467424已完成2 期

TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery

University Hospital of Split1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children

研究概览

简要总结

Two hundred children aged 1-12 years undergoing short surgery will be randomized into two groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used. Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU) will be recorded.

详细描述

Aim of the research: In this study investigators want to examine the effectiveness of the use of ketofol and a mixture of ketofol and lidocaine on the total consumption of opioids and on the postoperative recovery of pediatric patients. Investigators will evaluate the safety, efficacy, and outcomes of the anesthesia procedure with respect to the administration of different anesthetics, specific pharmakocinetic profiles and compare the length of recovery between patients in two groups.

Including criteria: children aged 1 to 12 years who underwent short surgery (up to 60 min).

Primary and secondary outcome measures: The primary outcome of this study will be extubation time and the secondary outcome will be time spend in PACU.

Description of the study: Each subject included in the study will be given general anesthesia with ketofol or ketofol and lidocaine, with the addition of fentanyl. After 20 s the LMA will be placed. Maintenance of anesthesia will be performed using an air / oxygen mixture (50% / 50%) and an infusion of ketofol or ketofol and lidocaine. Ketofol will be prepare in a ratio of 1: 4 for induction and 1: 7 for maintenance. The same mixtures of ketofol will be added 1 ml of 2% lidocaine for the second group of patients. After extubation, patients will be transferred to the PACU.

研究设计

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

入排标准

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

入选标准

  • surgical procedures max 60 min ASA I and II

排除标准

  • ASA > II surgical procedures longer than 60 min

研究组 & 干预措施

Pediatric anesthesia with ketofol

Experimental

ketamine, propofol

干预措施: ketamine, propofol (Drug)

Pediatric anesthesia with ketofol plus lidocaine

Experimental

ketamine, propofol, lidocaine

干预措施: ketamine, propofol, lidocaine (Drug)

结局指标

主要结局

Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children

时间窗: up to 600 seconds

Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU

时间窗: up to 40 minutes

次要结局

  • Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption(up to 60 minutes)

研究者

发起方
University Hospital of Split
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana N Biliškov, MD

Pediatric anesthesiologist

University Hospital of Split

研究点 (1)

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