跳至主要内容
临床试验/CTRI/2025/11/098182
CTRI/2025/11/098182尚未招募Phase 3 4

COMPARISON OF EFFECT OF DEXMEDETOMIDINE AS BOLUS OR LOW-DOSE INFUSION FOR THE PREVENTION OF EMERGENCE AGITATION UNDER SEVOFLURANE ANAESTHESIA IN PAEDIATRIC PATIENTS

tarun shekhar1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年12月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
76
试验地点
1

研究概览

简要总结

Emergence agitation EA is a common problem seen in children after they recover from sevoflurane anesthesia with reported rates ranging from 10 to 80 percent It is characterized by restlessness crying confusion and uncontrolled body movements during recovery Although it usually settles on its own EA can cause issues such as self injury bleeding accidental removal of intravenous lines and a longer stay in the post anesthesia care unit PACU

The exact causes of EA are complex and involve several factors including postoperative pain rapid awakening in an unfamiliar environment anxiety and sometimes low oxygen levels Sevoflurane is a widely used inhalational anesthetic because it allows quick induction smooth maintenance and stable heart function However compared to agents like halothane or propofol it has a higher risk of causing EA

To prevent EA different drugs have been tried including propofol midazolam ketamine and alpha two adrenergic agonists such as clonidine and dexmedetomidine Among these dexmedetomidine has shown special promise because of its calming pain relieving and anti anxiety properties It has been proven to reduce both the occurrence of EA and the need for pain relieving opioids However there is still uncertainty about the best dose to use Higher doses of 0 point 5 micrograms per kilogram or more are effective but can cause side effects like slow heart rate low blood pressure and delayed removal of the breathing tube Lower doses between 0 point 2 and 0 point 4 micrograms per kilogram may offer a safer balance between effectiveness and stable vital signs

Previous research has used both single bolus doses and continuous infusions of dexmedetomidine with mixed results A meta analysis has confirmed its benefit in preventing EA though it may slightly delay recovery from anesthesia and PACU discharge Because there is no clear agreement on the most effective dose or method this study aims to compare dexmedetomidine given as a single bolus versus a low dose infusion for preventing emergence agitation in children

研究设计

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

入排标准

年龄范围
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • ASA classification I-II
  • Age between 2-12 years
  • Undergoing lower abdominal surgery like (Hernia Repair, Orchidopexy, Meckel’s Diverticulectomy, Circumcision, Anorectal malformation repair) with sevoflurane anaesthesia.

排除标准

  • No consent
  • Developmental delay.
  • Congenital airway or cardiac disorders.
  • History of allergy to study medications.
  • Psychological disorders, epilepsy.

研究者

发起方
tarun shekhar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Tarun shekhar

Armed forces medical college

研究点 (1)

Loading locations...

相似试验