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临床试验/CTRI/2024/05/067484
CTRI/2024/05/067484尚未招募4 期

Comparison of premedication with intranasal Dexmedetomidine and Fentanyl combination with Midazolam and Fentanyl combination in children

Dr Nishtha Vij1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare ease of parental separation in children undergoing elective surgery by premedication with intranasal combinations of Fentanyl and Dexmedetomidine with intranasal Fentanyl and Midazolam.

研究概览

简要总结

Premedication in children undergoing surgeries plays a pivotal role in alleviating anxiety, promote relaxation and facilitate smooth induction of anaesthesia. Various drugs have been used as premedication out of which Dexmedetomidine, a highly selective alpha 2  adrenoreceptor agonist has been increasingly used owing to its various benefits. Fentanyl is a synthetic opioid which acts on mu-opioid  receptors to produce analgesia. Midazolam is a benzodiazepam that causes sedation  , anterograde amnesia, and hypnosis by acting on GABA receptors on CNS. Here we are trying to compare intranasal drug combinations of Fentanyl  and Dexmedetomidine with Fentanyl and Midazolam as premedication in children aged 2-6 years  undergoing elective surgery under general anaesthesia. The methodology and  administration of drug shall be explained in detail with a written well informed consent from the parents. The children shall be divided into two groups of 30 each using block randomisation technique (Group I will receive intranasal Fentanyl 2mcg/kg and Dexmedetomidine 1 mcg/kg and Group II will receive Fentanyl 2mcg/kg and Midazolam 0.2 mg/kg) using mucosal atomising device. Patient will be taken to pre op room and baseline vitals shall be noted, child will be premedicated with allocated drug group and observed for 30-60 minutes , vital parameters and sedation score shall be noted then ease of parental separation shall be noted using appropriate scale. Patient shall be taken to ot, standard anaesthetic protocol shall be followed, sedation  score upon arrival and Mask acceptance score using appropriate scale, hemodynamic parameters shall be noted. After neuromuscular reversal, child will be shifted to post operative care unit and sedation score, FLACC Scale for postoperative pain and vital parameters shall be recorded every 15 minutes uptill 1 hour postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • All patients of age group (2-6) years ASA grade 1 undergoing elective surgery under general anesthesia with supraglottic airway device or endotracheal tube.

排除标准

  • Patients with active upper airway disease
  • Patients at risk for airway obstruction
  • Patients with neurodevelopmental delay.

结局指标

主要结局

To compare ease of parental separation in children undergoing elective surgery by premedication with intranasal combinations of Fentanyl and Dexmedetomidine with intranasal Fentanyl and Midazolam.

时间窗: Parental separation assessed once at (30-60) minutes post drug intervention.

次要结局

  • Assessment of:(1. Preoperative sedation using 4 point sedation scale)

研究者

发起方
Dr Nishtha Vij
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nishtha Vij

VMMC and Safdarjung Hospital

研究点 (1)

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