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临床试验/CTRI/2025/08/092514
CTRI/2025/08/092514尚未招募不适用

ADMIRE study: Anaesthesia Decision and Management in IRreversible Electroporation procedures

未提供1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
89
试验地点
1
主要终点
To describe adverse events during Irreversible Electroporation at our centre- Tata memorial hospital, Mumbai

研究概览

简要总结

“Irreversible Electroporation” is a method of destroying tumor cells with the use of high voltage electric currents delivered very close to the tumour, with the help of specialised needles which are placed with the help of CT guidance by Interventional Radiologists, causing death of the tumour cells without affecting nearby structures like blood vessels and nerves. However, the high voltage current carries a risk of causing side effects like- increase or decrease of heart rate, an increase or decrease of blood pressure, and movement of muscles. Other side effects can be decreased body temperature of patients due to the cold environment of the IR suite and post-procedure pain.

Very few centers offer this modality of treatment, and our anaesthesia technique for these procedures is still evolving. Our study aims to look at data retrospectively into the incidence of these adverse events, which will help us formulate a plan for safer and better management. Following which we plan to prospectively observe for adverse events and postoperative pain.

For the retrospective cohort, data will be collected from electronic medical records of our hospital. For prospective cohort, all eligible patients will be consented a day prior the procedure. They will receive anaesthesia according to the current standard of care. Anesthesia management will be as per discretion of anaesthetist conducting the case. All patients will be followed up by study team till discharge from hospital. All data will be collected from the case record form and electronic medical records. No biological samples will be taken from the patient. No additional hospital visits will be required.

There are no risk factors as this is an observational study and hence there will be no direct contact with the patient. This study will help guide anaesthesia practice to improve patient care in the future of this procedure.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • All patients who underwent and will undergo Irreversible Electroporation procedure from 1st January 2020.

排除标准

  • Patient who refuse to consent in the prospective group of the study.

结局指标

主要结局

To describe adverse events during Irreversible Electroporation at our centre- Tata memorial hospital, Mumbai

时间窗: 24 hours from start of the procedure (From induction of anaesthesia till end of IRE procedure and immediate postoperative)

次要结局

  • Interference of IRE on Electrocardiography monitoring(24hours from start of procedure (induction of anaesthesia))
  • Effect of electrical pulses on Bispectral Index monitoring(24 hours from start of procedure (induction of anaesthesia))
  • Intraoperative & postoperative requirement of pain killers & the factors affecting the same (for example, age, sex)(From Start of procedure till 1 week of postoperative period)
  • The benefits of a Departmental protocol in reducing the intraoperative & postoperative adverse events(24 hours from start of procedure (induction of anaesthesia))

研究者

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

Dr Sumitra Bakshi

Tata Memorial Hospital

研究点 (1)

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