跳至主要内容
临床试验/CTRI/2025/09/095383
CTRI/2025/09/095383尚未招募不适用

A randomized comparative study of intranasal atomized dexmedetomidine versus ketamine as a premedication in children undergoing adenotonsillectomy in general anaesthesia at SMS Medical College Jaipur

Department of Anaesthesia Sawai Man Singh Medical College Jaipur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.To assess and compare the degree of sedation using the University of Michigan Sedation Scale (UMSS) between intranasal atomized dexmedetomidine versus ketamine.

研究概览

简要总结

Paediatric  patients present a unique set of challenges to the anaesthetist as preoperative anxiety in children leads to a difficulty in parental separation, i.v. cannulation, induction of anaesthesia, greater analgesic requirements and emergence agitation .Hence, the administration of balanced short-acting sedative agents with minimal risk of respiratory dysfunction is recommended under close monitoring of vitals. Dexmedetomidine is a selective alpha 2 agonist similar to clonidine, but with higher affinity to the alpha 2 receptor. It produces dose-dependent sedation, anxiolysis, and analgesia without respiratory depression and minimal effect on respiratory rate and tidal volume. Ketamine acts on the N methyl D aspartate receptor (NMDA R) producing a dissociative anesthesia. Ketamine is known to reduce central sensitization to pain, decrease overall opioid utilization, and produce effective sedation level. Oral administration has low bioavailability. Parenteral and intramuscular routes are invasive and painful. Intranasal application is a relatively non-invasive and easy route of administration which has the additional benefit of not requiring patient cooperation. With this background, we have planned this study to compare the efficacy of intranasal atomized dexmedetomidine versus ketamine as a premedication for anxiolysis and sedation in pediatric patients undergoing adenotonsillectomy in general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
3.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1.Children scheduled for adenotonsillectomy under general anaesthesia.
  • 2.Patients belonging to American Society of Anaesthesiologists (ASA) class I and II.
  • 3.Patient’s parents willing to give informed written consent.

排除标准

  • 1.Patients with known allergies to dexmedetomidine or ketamine.
  • 2.Patients with weight greater than 25 kg.
  • 3.Patients with any congenital anomaly or syndrome.
  • 4.Patients with history of seizures.
  • 5.Patients with upper respiratory tract infection.
  • 6.Patients with airway malformations or anticipated difficult airway.
  • 7.Patients with intellectual disability.
  • 8.Patients involved in any other study.

结局指标

主要结局

1.To assess and compare the degree of sedation using the University of Michigan Sedation Scale (UMSS) between intranasal atomized dexmedetomidine versus ketamine.

时间窗: 10 minutes, 20 minutes, 30 minutes

2.To assess and compare the ease of parental separation using Parental Separation Anxiety Score (PSAS) between the two groups

时间窗: 10 minutes, 20 minutes, 30 minutes

次要结局

  • 1.To assess and compare mask acceptance using Mask Acceptance Score (MAS) between the two groups .(2.To assess and compare the ease of venous cannulation using Groningen Distress Rating Scale (GDRS) between the two groups.)

研究者

发起方
Department of Anaesthesia Sawai Man Singh Medical College Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mamta Sharma

Sawai Man Singh Medical College Jaipur

研究点 (1)

Loading locations...

相似试验