跳至主要内容
临床试验/CTRI/2024/10/075797
CTRI/2024/10/075797尚未招募不适用

An observational prospective study for drug protocol in DISE in Paediatric population

Institution fluid research funding1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年11月5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
75
试验地点
1
主要终点
To determine optimal dosage of anaesthetic drugs to be administered to paediatric patients undergoing and assess for successful completion of DISE

研究概览

简要总结

The goal of DISE is to determine an anatomic site of obstruction for children with OSA. Literature shows, there is a low rate of agreement on how to perform DISE. Although many institutions have a standard DISE drug protocol, none has been widely accepted. This wide variability of DISE protocol compromises DISE findings which in turn affect patient Management. This study aims at deriving a standard drug protocol to perform DISE at our institution. After pre-operative assessment of patients, the pre-existing medical conditions and drug allergies will be noted and they will be premedicated with Syrup trichloryl 75 mg/kg one hour prior to entry to OR (Operating room). They will be monitored by a pulse oximeter. On receiving the patient in OR, they will be kept in a quiet room with dimmed lights with few people. Child will be induced with inhalational agents (Sevoflurane + Nitrous oxide + Oxygen) and peripheral IV catheter will be placed once patient is in deep plane of anaesthesia. Dexmedetomidine infusion will be administered at 0.5mcgs/kg IV over 10 minutes. Ketofol (ketamine 100-200 mcg/kg/min + propofol 50-100 mcg/kg/min ) will be titrated according to the BIS value between 65-85(8) and attempt to insert scope will be made. Patient vitals (heart rate, respiratory rate, blood pressure, saturation) will be monitored during the procedure and additional use of extra doses of ketofol will be documented. Patient’s sedation level will be monitored using BIS monitor and time taken to complete the study will be documented. Any untoward events or other factors hindering the successful completion of study will be taken into account. Following DISE, the patient will undergo the proposed procedure, adenoidectomy or tonsillectomy according to the standard protocol. If patient is posted only for DISE, patient will be monitored in recovery room and discharged according to modified Aldrete score.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • All patients in above mentioned age groups and less than 30kg weight.

排除标准

  • All patients who donot fall in the inclusion criteria age group and more than 30kg weight.

结局指标

主要结局

To determine optimal dosage of anaesthetic drugs to be administered to paediatric patients undergoing and assess for successful completion of DISE

时间窗: January 2024 to June 2025

次要结局

  • 1.To identify possible side effects associated with the anaesthetic drugs for example- haemodynamic instability, total airway collapse.(2.• To ensure smooth conduct of procedure with the anaesthetic drugs being used.)

研究者

发起方
Institution fluid research funding
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sakshi Harris

CMC VELLORE

研究点 (1)

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