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临床试验/CTRI/2025/10/095554
CTRI/2025/10/095554尚未招募不适用

Incidence of perioperative ECG changes during and after cancer surgeries:a prospective observational study

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To study the incidence of new ECG changes during cancer surgery and in the PACU after cancer surgeries

研究概览

简要总结

ECG is a simple and cost effective investigation for cardiac risk assessment especially in the patients undergoing surgeries. Numerous studies have shown that preoperative ECG abnormalities are associated with increased risk of postoperative mortality and  morbidity. However, the role of postoperative ECG monitoring has not been studied extensively. This prospective observational study is being done to determine the incidence of perioperative ECG changes during and after cancer surgeries.

As it is a standard  care in our institution to do a 12 lead ECG in the patients who develop new ECG changes or have hemodynamic instability in the perioperative period, All these patients who develop new changes  compared to their baseline ECG either intraoperatively or in the post operative period will be included in the study and followed up till they get discharged from the post Anaesthesia care unit.

All the data will be collected from the case record form and electronic medical records. No biological samples will be taken from patient. No additional hospital visits are needed.

There are no risk factors associated with the study as it is a prospective observational study. This study will help in guiding the study team to recognize early warning signs and take appropriate measures to prevent and manage cardiac complications.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All adult patients age more than 18years undergoing elective or emergency cancer surgeries in the major OT complex having new ECG changes in intraoperative or the postoperative period in PACU.

排除标准

  • Patients not having preoperative baseline 12-lead ECG
  • Consent refusal by the patient
  • Minor procedures and biopsies performed in peripheral locations.

结局指标

主要结局

To study the incidence of new ECG changes during cancer surgery and in the PACU after cancer surgeries

时间窗: Intraoperative and in Post Anaesthesia Care Unit (PACU) till discharge

次要结局

  • 1. To study the proportion of patients having hemodynamic instability along with ECG changes(2. To observe the proportion of patients requiring additional cardiology or physician consultation due to new ECG changes)

研究者

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

Dr Sukhada Savarkar

Tata Memorial Hospital

研究点 (1)

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