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临床试验/CTRI/2024/09/074237
CTRI/2024/09/074237招募中4 期

Comparison of ‘Two models’ Anaesthesiologist-Technician verses Anaesthesiologist- Junior Anaesthesiologist models to evaluate ‘anaesthetic ready time’ in orthopaedic infant surgery. A Randomized Controlled Trial.

Sancheti Institute of Orthopedics and Rehabilitation1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年10月4日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
130
试验地点
1
主要终点
total time required to perform a combined general and regional anesthesia.

研究概览

简要总结

Paediatric regional anaesthesia (RA) today is one of the fastest growing and exciting aspects of paediatric anaesthesia, which requires an ongoing fervour to learn. Application of paediatric regional anaesthesia in neonates, infants, toddlers and children is undertaken to treat perioperative pain without disturbing the physiological milieu. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids. Considerable progress has been made in the practice of PRA over the past few years including the availability of information on safety and the incorporation of ultrasound guidance. The primary aim of the study was to determine whether the two-attending anaesthesiologist model decreases the amount of operating room time required for a combined general anaesthesia and ultrasound-guided regional nerve block for lower limb surgery [caudal block and or supra-inguinal fascia iliaca block] in children requiring a simultaneous general anaesthetic as compared to a single anaesthesiologist model.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • ASA physical status grade I and II paediatric patients undergoing infra umbilical surgeries under General anaesthesia.

排除标准

  • Parenal or guardian refusal
  • Allergy or hypersensitivity to any drugs
  • Known hypersensitivity to dexmedetomidine
  • Pre-existing cardiovascular, respiratory, cerebrovascular, neurological disease or coagulation disorders
  • Local Infection at caudal punvture site.

结局指标

主要结局

total time required to perform a combined general and regional anesthesia.

时间窗: time will be recorded one time immediately after GA and regional block is given

次要结局

  • The time of the start for aseptic prep of the skin(Surgeon satisfaction.)

研究者

发起方
Sancheti Institute of Orthopedics and Rehabilitation
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sandeep Diwan

Sancheti Institute of Orthopedics and Rehabiliation

研究点 (1)

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