跳至主要内容
临床试验/CTRI/2022/08/045085
CTRI/2022/08/045085尚未招募不适用

Comparing Opioid Versus Non-Opioid Anaesthesia Technique For Extubation Time In Neonates Undergoing Infraumbilical Surgeries

Dr Abhinav Siroha1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月9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
40
试验地点
1
主要终点
TO COMAPARE EXTUBATION TIME BY USING OPIOID AND NON-OPIOID TECHNIQUE FOR ANAESTHESIA IN NEONATES UNDERGOING INFRAUMBILICAL SURGERIES

研究概览

简要总结

Neonates, being a high-risk population often need post-operative mechanical

ventilation, which leads to higher mortality and stress on resources in developing countries

like India with limited neonatal intensive care unit and ventilator facilities, inadequate

resources and a lack of trained medical personnel. This prompts us to explore

methods to minimize the intraoperative anaesthetic exposure and opioid techniques to

aid early extubation which accelerate recovery, shorten length of hospital stay and decrease

the medical expense.

There is a paucity of literature regarding this study between opioid versus non opioid

anaesthesia techniques when used in conjunction with general anaesthesia in terms of time

required to extubate the neonate and measurement of pain in the post operative period.

Hence, we are conducting an observational study in which one group would be provided

analgesia via caudal route and the other group via iv opioid and then the time required for

extubation would be measured.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • •NEONATES UNDERGOING INFRAUMBILICAL SURGERIES.

排除标准

  • •NEONATES WITH CONGENITAL ABNORMALITY 2.ALREADY INTUBATED NEONATE ON VENTILATORY SUPPORT 3.CONTRAINDICATIONS TO CAUDAL BLOCK.

结局指标

主要结局

TO COMAPARE EXTUBATION TIME BY USING OPIOID AND NON-OPIOID TECHNIQUE FOR ANAESTHESIA IN NEONATES UNDERGOING INFRAUMBILICAL SURGERIES

时间窗: OUTCOME (EXTUBATION TIME) WOULD BE ASSESSED WHEN LAST SKIN SUTURE OF THE ONGOING SURGERY IS PLACED TO THE RETURN OF PROTECTIVE AIRWAY REFLEXES (GAG REFLEX) AND SPONTANEOUS BREATHING

次要结局

  • TO ASSESS AND COMPARE THE POST OPERATIVE PAIN SCORES BETWEEN OPIOID AND NON-OPIOID ANESTHESIA TECHNIQUE(Pain will be assessed using Neonatal Infant Pain Scale (NIPS) at 5th minute and later every 15 minutes for the first 1 hour, every 30 mins for next 2 hours and then hourly till total of six hours after extubation.)

研究者

发起方
Dr Abhinav Siroha
申办方类型
Other [self]

研究点 (1)

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