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临床试验/NCT05474937
NCT05474937Unknown不适用

Nasal Inhalation of Sevoflurane Versus Midazolm,Ketamine and Propofol For Pediatric Undergoing Upper Gastrointestinal Endoscopy

Zagazig University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
74
试验地点
1
主要终点
sedative effect

研究概览

简要总结

In the field of pediatric gastroenterology, upper gastrointestinal endoscopy has established itself as a diagnostic and therapeutic tool. In order to increase patient tolerance during this procedure, deep sedation is essential. Children are at a higher risk of serious adverse effects from procedural sedation; thus, their safety is a primary issue throughout this procedure. Multiple studies have been done to find the ideal method for procedural sedation in terms of ease of administration, quality, safety of sedation and recovery profile, but the consensus seems lacking. In this study we will compare between nasal inhalation of sevoflurane versus intravenous ketamine, midazolam and propofol for pediatrics undergoing upper gastrointestinal endoscopy.

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
None

入排标准

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

入选标准

  • A consent from the parents or 1st degree relative.
  • Both sexes.
  • Pediatric patients aged 1year to 4 years old undergoing
  • elective upper GI endoscopy.
  • ASA class I &II.
  • BMI between 5th percentile and the 85th percentile (http://www.kidshealth.org).

排除标准

  • Hypersensitivity to drugs included in the study.
  • Difficult airway or known airway problems.
  • Active bleeding from esophageal varices.
  • Respiratory and cardiac problems.
  • Neurological disorders

研究组 & 干预措施

inhalational Sevoflurane

Active Comparator

In the field of pediatric gastroenterology, upper gastrointestinal endoscopy has established itself as a diagnostic and therapeutic tool. In order to increase patient tolerance during this procedure, deep sedation is essential. Children are at a higher risk of serious adverse effects from procedural sedation; thus, their safety is a primary issue throughout this procedure. Multiple studies have been done to find the ideal method for procedural sedation in terms of ease of administration, quality, safety of sedation and recovery profile, but the consensus seems lacking. In this study we will compare between nasal inhalation of sevoflurane versus intravenous ketamine, midazolam and propofol for pediatrics undergoing upper gastrointestinal endoscopy.

干预措施: Sevoflurane Inhalation Solution (Drug)

inhalational Sevoflurane

Active Comparator

In the field of pediatric gastroenterology, upper gastrointestinal endoscopy has established itself as a diagnostic and therapeutic tool. In order to increase patient tolerance during this procedure, deep sedation is essential. Children are at a higher risk of serious adverse effects from procedural sedation; thus, their safety is a primary issue throughout this procedure. Multiple studies have been done to find the ideal method for procedural sedation in terms of ease of administration, quality, safety of sedation and recovery profile, but the consensus seems lacking. In this study we will compare between nasal inhalation of sevoflurane versus intravenous ketamine, midazolam and propofol for pediatrics undergoing upper gastrointestinal endoscopy.

干预措施: Midazolam, Ketamine and Propofol (Drug)

Intravenous Ketamine, Midazolam and Propofol group

Active Comparator

Preoxygenation with 100% O2 for 1 minute, by proper sized face mask. Patients in Ketamine -midazolam -propofol (KMP) group will receive 1-1.5 mg/kg IV ketamine and 0.05mg/kg IV Midazolam and 1mg/kg IV Propofol as induction dose then followed by incremental doses of 0.5 mg/kg IV Propofol alone for maintenance and if procedure is prolonged propofol infusion at 100 μg/kg/min is given for maintenance of sedation. Induction dose will be considered as adequate if adequate jaw relaxation for endoscope insertion and Modified Ramsay Sedation Score (MRSS) ≥7 occurs with maintenance of spontaneous respiration. Induction time will be considered as time from beginning of IV agent to achievement of MRSS ≥7. After endoscope insertion, maintenance of oxygenation by nasal cannula at flow twice the minute ventilation of the patient.

干预措施: Sevoflurane Inhalation Solution (Drug)

Intravenous Ketamine, Midazolam and Propofol group

Active Comparator

Preoxygenation with 100% O2 for 1 minute, by proper sized face mask. Patients in Ketamine -midazolam -propofol (KMP) group will receive 1-1.5 mg/kg IV ketamine and 0.05mg/kg IV Midazolam and 1mg/kg IV Propofol as induction dose then followed by incremental doses of 0.5 mg/kg IV Propofol alone for maintenance and if procedure is prolonged propofol infusion at 100 μg/kg/min is given for maintenance of sedation. Induction dose will be considered as adequate if adequate jaw relaxation for endoscope insertion and Modified Ramsay Sedation Score (MRSS) ≥7 occurs with maintenance of spontaneous respiration. Induction time will be considered as time from beginning of IV agent to achievement of MRSS ≥7. After endoscope insertion, maintenance of oxygenation by nasal cannula at flow twice the minute ventilation of the patient.

干预措施: Midazolam, Ketamine and Propofol (Drug)

结局指标

主要结局

sedative effect

时间窗: 1 hour

Sedative effect will be assessed in terms of induction time success of induction and maintenance

次要结局

  • adverse events(2 hours)

研究者

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

Salih Salim Salih Bahri

Resident of anesthesia and intensive care

Zagazig University

研究点 (1)

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