跳至主要内容
临床试验/CTRI/2023/11/060292
CTRI/2023/11/060292招募中不适用

AN OBSERVATIONAL STUDY OF ANAESTHETIC MANAGEMENTS IN CHILDREN UNDERGOING RADIOTHERAPY IN A TERTIARY CANCER CARE CENTRE: A PROSPECTIVE AUDIT

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年12月4日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
1) The method of management required i.e. anesthesia/ reward therapy/ distraction method/ none

研究概览

简要总结

As a tertiary cancer care centre, we at Tata Memorial Hospital witness a large number of pediatric oncology cases, both solid tumor and hematologic. Needless to say, cancer contributes significantly to the mortality and morbidity of pediatric patients. Most solid tumor cases require external beam radiotherapy (EBRT) at some point in their treatment course, whether with a curative or palliative intent (reduces pain, preserves organ function and maintains hollow organ lumen patency).

Anesthesia or procedural sedation may be required for the procedure depending on a variety of factors including the patient’s age, cognitive function, emotional maturity, pain, musculoskeletal deformities, treatment requirements (like the prone position), claustrophobia. Children are posted for 10-28 sessions of teletherapy or 8-10 sessions of brachytherapy. Usually, children less than 6-7 years and older children with claustrophobia require procedural sedation for radiotherapy, whereas, older children cooperate by distraction or reward.

This study will focus on the day-care anesthesia practices in pediatric RT (IV sedation/inhalational anesthesia), the outcomes, patterns of anesthesia (choice of Induction agent, route of administration, premedication, duration of procedure), recovery time, issues after patient’s discharge from the hospital, longevity of a peripheral IV access line, airway considerations (difficult airway, desaturation, laryngo-/bronchospasm, excessive secretions) in Tata Memorial Hospital, Mumbai over a period of 1 year, with interim analysis at 6 months or till 600 procedures and their outcomes are recorded, whichever is earlier.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Children of age 1 day-15 years
  • Children undergoing radiotherapy (brachytherapy or teletherapy)
  • Children referred for anesthesia.

排除标准

  • Children >15 years of age
  • Children not referred for anesthesia.

结局指标

主要结局

1) The method of management required i.e. anesthesia/ reward therapy/ distraction method/ none

时间窗: Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure

2) The pre-procedural fasting practices

时间窗: Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure

3) The pre-procedural medications administered

时间窗: Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure

4) Airway events & management during procedure

时间窗: Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure

5) Hemodynamic events & management during procedure

时间窗: Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure

6) Recovery after the procedure & management required

时间窗: Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure

次要结局

  • 1) Course of IV access(Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Madhavi Desai

Tata Memorial Centre

研究点 (1)

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