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临床试验/CTRI/2024/08/072649
CTRI/2024/08/072649尚未招募2/3 期

Comparison of effect of intravenous Dexmedetomidine and Midazolam on preoperative sedation in paediatric patients undergoing elective surgery under general anaesthesia

Dr Nazrana Nasrin Sultana1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年8月23日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
To compare the sedation score of IV Dexmedetomidine and Midazolam

研究概览

简要总结

One of the challenges in paediatric anaesthesia is to minimize distress for children in the OT room environment and to facilitate smooth induction of anaesthesia. This is often accomplished by prior administration of a sedative drug before transfer to the Operation room.Midazolam is the most common drug used for this purpose.(1) This is due to its sedative and anxiolytic properties (2). However, undesirable properties like restlessness and respiratory depression have made it a less than ideal premedication (3).

Dexmedetomidine is a newer alpha agonist with a more selective action on alpha adrenoceptor and a shorter half life (4). It provides sedation, anxiolysis and analgesia without respiratory depression (5).

The purpose of this study is to compare intravenous Midazolam and Dexmedetomidine as premedication in paediatric age group.

The null hypothesis of our study is that there is no significant difference between effect of intravenous Midazolam and Dexmedetomidine on preoperative sedation in paediatric patients undergoing elective surgery under general anaesthesia.

The study will be carried out in different Operation theatres of GMCH on paediatric patients in the age group 5-12 years.

References:

  1. Kain ZN, Caldwell-Andrews AA, Krivutza DM,Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anaesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: Results of a follow-up national survey. Anesth Analg. 2004;98:1252-9

  2. marshall J, Rodarte A, Blumer J, Khoo KC, Akbari B, Kearns G. Pediatric pharmacodynamics of midazolam oral syrup. Pediatric Pharmacology Research Unit Network. J Clin Pharmacol. 2000;40:578-89

  3. Kanegaye JT, Favela JL, Acosta M, Bank DE. High dose rectal Midazolam for pediatric procedures: A randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003;19:329-36

  4. Petroz GC, Sikich N, James M, van Dyk H, Shafer SL, Schily M. A phase 1, two-center study of the pharmacokinetics and pharmacodynamics of dexmedetomidine in children. Anesthesiology. 2006;105:1098-110

  5. June JH, Kim KN, Kim JY, Song SM: The effects of intranasal Dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017, 9:947-961. 10.1007/s12630-017

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
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Paediatric patients with ASA grade 1 undergoing elective surgery under general anaesthesia.

排除标准

  • Obese patients with BMI more than 30
  • Patients with anticipated difficult airway
  • Patients with sedation score less than 5.

结局指标

主要结局

To compare the sedation score of IV Dexmedetomidine and Midazolam

时间窗: 0 minutes, 10 minutes, at the time of extubation and 2 hours after extubation

次要结局

  • To compare the mask acceptance score in the two groups(At 10 minutes after drug administration just before induction)

研究者

发起方
Dr Nazrana Nasrin Sultana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nazrana Nasrin Sultana

Gauhati Medical College and Hospital, Guwahati

研究点 (1)

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