跳至主要内容
临床试验/CTRI/2025/11/096896
CTRI/2025/11/096896尚未招募不适用

Comparison of Intranasal Dexmedetomidine with Intranasal Midazolam as Premedication in Children Undergoing Elective Surgeries- A Randomised Controlled Trial.

未提供2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
To compare the preoperative sedation and response of child to parental separation, in patients receiving intranasal dexmedetomidine and intranasal midazolam as premedication.

研究概览

简要总结

After obtaining Institutional Ethics Committee clearance and explaining the study in detail, written informed consent will be procured from parents. The patients are randomized into two groups dexmedetomidine (group D) and midazolam (group M) by a computer generated randomization list prepared by an anaesthesiologist not involved in the study. The principal investigator is blinded to the computer generation of random numbers and sealed envelope method will be used during the conduct of study. The allotted patients will be kept nil per oral as per the standard fasting guideline protocol. The child is brought to the premedication room and are administered with either intranasal dexmedetomidine 1 mcg/kg or intranasal midazolam 0.2 mg/kg 30 minutes prior to the procedure on the day of surgery.  The premedication drug is prepared by a person not involved in the study, either of the drug is taken in a 2 ml syringe and is diluted to 2 ml. It is instilled into both the nostrils by the principal investigator using an atomiser. In the premedication room, the patient’s heart rate and SPO2 are monitored at 5 minutes interval. After 30 minutes, parental separation anxiety is assessed using appropriate score. The child is shifted to the operating theatre and standard ASA monitors are attached. All children are given Inhalational induction using sevoflurane followed by assessment of mask acceptance using Mask acceptance score. Tracheal intubation will be done after administration of standard non-depolarizing muscle relaxant, anaesthesia will maintained by O2 , air and sevoflurane and analgesia will provided by fentanyl and paracetamol. Ventilation will be controlled by either Jackson-Ree’s modification of Ayre’s T-piece or pediatric closed circuit. Residual neuromuscular paralysis will be reversed at the end of operation by appropriate dose of neostigmine and glycopyrrolate. In all patients heart rate, systolic blood pressure, diastolic blood pressure and mean arterial blood pressure are measured at baseline and at 5 min interval throughout the procedure.  Post extubation emergence agitation is assessed using the Cravero emergence agitation score. Hemodynamic parameters are measured postoperatively in the recovery room till the patient is shifted.

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
1.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Age 1 to 8 years
  • ASA I and II
  • Elective surgeries.

排除标准

  • Patients with respiratory tract infections or nasal obstruction.
  • Congenital anomalies to nasal or oral cavity
  • H/O allergy
  • Parental refusal to consent.

结局指标

主要结局

To compare the preoperative sedation and response of child to parental separation, in patients receiving intranasal dexmedetomidine and intranasal midazolam as premedication.

时间窗: 0,5,10,15,20,25,30 MINUTES

次要结局

  • Preoperative sedation score(0,5,10,15,20,25,30 MINUTES)
  • Mask acceptance(After 30 MINUTES)
  • Post operative agitation(After surgery)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Anjana B S

Malankara Orthodox Syrian Church Medical College

研究点 (2)

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