To study the requirement of intravenous propofol after premedication with intranasal ketamine and dexmedetomidine in pediatric patients undergoing upper GI endoscopy
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the dosage of intravenous propofol after premedication with intranasal dexmedetomodine and ketamine and induction with IV propofol and ketamine during upper GI Endoscopy.
研究概览
简要总结
In this study pediatric patients aged 1 to 5 years will be given intranasal premedication with ketamine and dexmedetomidine 30 minutes before undergoing upper GI endoscopy. All the vitals will be noted and the sedation score and anxiety score will be noted. The the patient will be shifted to endoscopy suite, Heart rate , BP, SPO2 will be noted . All the patients will be given induction dose of propofol 1mg/kg IV and ketamine 1mg/kg IV will be given. Further doses will be given on patient movement as per anesthesiologist’s discreetion.After the procedure the vitals will be note and the patient will be shifted when awake. Any adverse event like desaturation or bradycardia will be noted
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients undergoing upper GI Endoscopy 2.parents agreeing to participate in study 3.Adequate NPO status.
排除标准
- •Inadequate NPO status Known allergy to given drugs Vascular disorders like NCPF ,EHPVO, Budd chiari syndrome Massive ascitis H/O upper airway obstruction, severe respiratory disease, or congenital heart disease Patients with H/O developmental delay or behavioral disorders Parental refusal to participate in study.
结局指标
主要结局
To compare the dosage of intravenous propofol after premedication with intranasal dexmedetomodine and ketamine and induction with IV propofol and ketamine during upper GI Endoscopy.
时间窗: To compare the dosage of intravenous propofol after premedication with intranasal dexmedetomodine and ketamine and induction with IV propofol and ketamine during upper GI Endoscopy at 10 minutes , 15 minutes , 20 minutes during endoscopy
次要结局
- 1.Hemodynamics- HR, BP , SPO2(2.Sedation score,)
研究者
Jasmin Bulbul
Institute of Liver and Biliary Sciences