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临床试验/CTRI/2025/08/093381
CTRI/2025/08/093381尚未招募不适用

Current practices of perioperative management strategy for patients on RAAS inhibitors undergoing major oncological surgery and perioperative outcomes - An observational study.

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
1
主要终点
To record perioperative management strategy for patients on RAAS inhibitors.

研究概览

简要总结

The study is a prospective observational study being conducted at a tertiary cancer hospital to evaluate current perioperative management strategies in patients on renin angiotensin aldosterone system RAAS inhibitors undergoing major elective oncological surgeries Hypertension is a common comorbidity in cancer patients and RAAS inhibitors such as ACE inhibitors and ARBs are widely used for its management However there is no uniform guideline on whether to continue or withhold these medications in the perioperative period

The study aims to assess the effects of these management strategies on perioperative hemodynamic stability blood loss vasoactive drug use and transfusion requirements Approximately 500 adult patients on RAAS inhibitors scheduled for major elective oncological procedures will be enrolled over a period of one year

Data on intraoperative and 24 hour postoperative blood pressure variations, use of vasoactive agents and transfusions will be collected This study seeks to provide insight into current practices and their outcomes potentially guiding future recommendations for perioperative management of RAAS inhibitors

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

  • 1 Patients aged greater than 18years with American Society of Anesthesiologists grade 2 planned for major electiveoncologicalsurgery 2 Patients on RAAS inhibitors.

排除标准

  • 1 patients who are on multiple antihypertensives excluding ACEIs and ARBs 2 Emergency or unplanned surgeries 3 Day care or minor procedures 4 Patients with severe renal dysfunction 5 Patient with EF less than 35 percent 6 uncontrolled hypertension.

结局指标

主要结局

To record perioperative management strategy for patients on RAAS inhibitors.

时间窗: On the day of surgery

次要结局

  • To record the percentage of hypertensive patients receiving RAAS inhibitors(The no 1 secondary outcome will be recorded at the end of the study)
  • To note incidence of intraoperative hypotension(will be assessed during the surgery)
  • To note the requirement of vasoactive agents(will be assessed during the surgery)
  • To evaluate for intraoperative and postoperative blood pressure changes if preoperatively bridging done with alternative antihypertensive agent(will be assessed during the surgery)
  • To note intraoperative blood loss and the amount of blood products transfused(The postoperative blood pressure changes will be assessed for a period of 24 hours at time points immediately after shifting to PACU then after 1 hour 4 hours 8 hours 12 hours and 24 hours)
  • To note the episodes of hypotension /hypertension intraoperatively(will be assessed during the surgery)

研究者

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

Dr Vijaya Patil

Tata Memorial Hospital

研究点 (1)

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