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临床试验/CTRI/2025/07/090620
CTRI/2025/07/090620尚未招募不适用

Evaluating the clinical relevance and cost effectiveness of routine pre-operative investigation in elective surgeries: A prospective observational study

Bhavana N B1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年7月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
156
试验地点
1
主要终点
To determine the proportion of routine pre-operative tests that adhere to established guidelines like those from the national institute of health and care excellence (NICE) and American society of anaesthesiologists (ASA) status.

研究概览

简要总结

The study will comprise individuals who will attend a pre-anaesthesia check-up(PAC) prior to surgery in the preoperative ward for evaluation and risk stratification before planned elective procedures. Their demographic information, date of arrival in pre-anaesthesia check-up (PAC), American Society of Anaesthesiologist’s (ASA) status, and grade of surgery according to NICE guidelines 2016 will be documented. The participants will be randomly assigned using the envelope method. The number of investigations completed prior to arrival at pre-anaesthesia check-up (PAC), as well as the outcomes of normal and abnormal tests, will be recorded. A test will be judged abnormal if it does not fall within the normal limits established by the institutional laboratory. According to the criteria, the test will be classified as indicated or unindicated. The number of abnormal tests and their significance will be expressed. All the patients will be followed up on subsequent pre-anaesthesia check-up (PAC) visits till one day prior to surgery and the total no. of pre-anaesthesia check-up(PAC) visits, any referral, further investigation and consequent delay will be confirmed pre-operatively. In the post-operative period, changes in the on-going management, alteration in the anaesthetic procedures, or monitoring plan will be noted. An abnormal test was considered impactful if it led to further evaluation, and significant if it altered perioperative management. Unnecessary tests, based on NICE guidelines, will be analyzed for cost implications. Diagnostic investigations will be excluded from this study. Any disease-specific investigation conducted based on a significant patient’s history or clinical investigations will not be regarded significant as they will not constitute regular investigations. A single anaesthesiologist will be responsible for collecting data throughout the trial. The designated anaesthesiologist will not be allowed to filter investigations or intervene in the pre-anaesthesia check-up (PAC) process of colleagues of similar rank. To avoid bias, the surgeon and anaesthesiologist will not be informed about the study. Patients examined by the designated anaesthesiologist will be excluded from the research.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.patients od ASA 1 and 2
  • Patients of all gender planned for elective surgery will be included in the study 3.the study included all the patients between 19-60 years
  • patients hospitalized for elective surgeries under general anaesthesia or regional anaesthesia will be included in the study.

排除标准

  • 1.Patients directly evaluated by the designated anaethesiologist will be excluded from the study 2.Emergency surgeries ,day care surgery ,and pregnant patients will be excluded
  • Diagnostic investigation will be excluded from the study.

结局指标

主要结局

To determine the proportion of routine pre-operative tests that adhere to established guidelines like those from the national institute of health and care excellence (NICE) and American society of anaesthesiologists (ASA) status.

时间窗: This outcome will be assessed in the pre-operative room and as well as in post operative period also

次要结局

  • To assess the cost -effectiveness of routine pre-operative investigations in the elective surgical cases.(This outcome will be assessed in the post -operative room)
  • To analyze the clinical relevance of abnormal test results in improving peri operative outcomes(This outcome will be assessed in the pre-operative room and as well as in post operative period)

研究者

发起方
Bhavana N B
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bhavana N B

yenepoya school of allied health sciences

研究点 (1)

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