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临床试验/NCT02732132
NCT02732132已完成4 期

A Comparison of the Sedation With Intermittent Bolus Midazolam-Ketamine Versus Intermittent Bolus Propofol-Fentanyl During Endoscopy in Children: Randomized Trial

Kanuni Sultan Suleyman Training and Research Hospital0 个研究点目标入组 238 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
238
主要终点
the effectiveness of sedation

研究概览

简要总结

The primary aim of this study was to investigate the efficiency and safety of midazolam plus ketamine versus fentanyl plus propofol administered to children undergoing UGE and to determine the most appropriate sedation protocol.

详细描述

The patients were given a spray of lidocaine 10% as a topical pharyngeal anaesthesia before sedation. Intravenous midazolam bolus dose 0.1 mg/kg (maximum 4 mg) was administered to Group A. Two minutes later, ketamine bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after ketamine application. Ketamine 0.5 mg/kg (maximum of 2 mg/kg) was added in two minute intervals if adequate sedation was not achieved initially. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a ketamine 0.5 mg/kg single dose was applied. Intravenous fentanyl bolus dose 1µg/kg was administered to Group B. Two minutes later, propofol bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after propofol application. Propofol 0.5 mg/kg was added in two minute intervals if adequate sedation was not achieved. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a propofol 0.5 mg/kg single dose was applied. None of the patients were given an antidote after the process during recovery.

All patients were monitored for peripheral oxygen saturation, heart rate (HR), respiratory rate, and RSS during the procedure. Oxygen (2L/min) by nasal cannula was given to all patients during the procedure. Hypoxia (peripheral oxygen saturation <90% during 60 seconds), apnea, laryngospasm, tachycardia (defined as 30% more than the average heart rate by age), bradycardia (30% less than the average heart rate by age), increase in oral secretions (more than enough to warrant aspiration), flushing, coughing and vomiting were assessed as complications and recorded.

研究设计

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

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All the patients were in ASA (American Society of Anesthesiologists) physical status I or II.

排除标准

  • Patients with respiratory tract infections, glaucoma, psychosis, porphyria, hypertension, metabolic or neurologic diseases, increased intracranial pressure and intracranial mass, and patients known to be allergic to the drugs used were excluded from the study.

研究组 & 干预措施

Ketamine and Midazolam

Active Comparator

ketamine 1 mg/kg midazolam 0.1 mg/kg

干预措施: Ketamine and Midazolam (Drug)

Propofol and Fentanyl

Experimental

propofol 1 mg/kg fentanyl 1 mcg/kg

干预措施: Propofol and Fentanyl (Drug)

结局指标

主要结局

the effectiveness of sedation

时间窗: six months

the effectiviness of midazolam plus ketamine versus fentanyl plus propofol according to a modified Ramsay sedation score

次要结局

  • procedure time(six months)
  • adverse events that are related to study drugs(six months)
  • recovery time(six months)

研究者

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

Ulas Emre Akbulut

Medical Doctor

Kanuni Sultan Suleyman Training and Research Hospital

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