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临床试验/CTRI/2025/07/091170
CTRI/2025/07/091170招募中不适用

Preoperative autonomic function assessment as a predictor of post induction hypotension in diabetic patients undergoing elective surgeries

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
214
试验地点
1
主要终点
To assess whether preoperative autonomic function tests can predict post induction

研究概览

简要总结

Diabetes mellitus is a prevalent chronic disease in India, leading to multiple anesthetic challenges including cardiovascular instability and autonomic dysfunction. Diabetic autonomic neuropathy impairs cardiovascular reflexes and predisposes patients to severe post-induction hypotension (PIH), which is associated with poor perioperative outcomes including acute renal damage, major adverse cardiac events, and increased mortality risk. Current evidence regarding the predictive value of autonomic function tests for PIH in diabetic patients remains insufficient.

Aim

To assess whether preoperative autonomic function tests can predict post induction hypotension in diabetic patients undergoing elective surgeries under general anaesthesia.

Primary Objective

To assess the correlation  betweenvariables derived from  three autonomic function tests - Electrochemical Skin Conductance (ESC), Baroreceptor Sensitivity (BRS), and Heart Rate Variability (HRV) - with incidence of post induction hypotension in diabetic  patients undergoing elective surgeries under general anaesthesia.

Secondary Objectives

  1. To determine the incidence of Post-Induction Hypotension (arterial hypotension occurring during the first 20 minutes after anesthesia induction)
  2. To determine the incidence of Early Intraoperative Hypotension (arterial hypotension up to 30 minutes post-incision)
  3. To evaluate the need and amount of vasopressor administration to correct hypotension

Methodology

This single-center prospective observational cohort study will enroll 214 diabetic patients (ASA I-III, aged 18-80 years) undergoing elective surgery under general anesthesia. Participants will undergo three non-invasive autonomic function tests one or 2 days  before surgery: Electrochemical skin conductance (ESC) via Sudoscan®, Heart rate variability(HRV) analysis, and Baroreceptor sensitivity test (BRS) testing. During surgery, standardized monitoring will record hemodynamic parameters every 2 minutes for 20 minutes post-induction and 30 minutes post-incision. Hypotension is defined as MAP <65 mmHg, SBP <90 mmHg, or 30% drop in MAP from baseline.

Outcome Measures

  1. To derive CAN score using electrochemical skin conductance ,high and low frequency power in baroreflex sensitivityand time domain and frequency domain paramaters in heart rate variability test.
  2. To determine the incidence of post induction hypotension (PIH),i.e. arterial hypotension occuring during first 20 mins after anesthesia induction.
  3. To determine the incidence of early intraoperative hypotension(eIOH), i.e. arterial hypotension upto 30 mins post incision.
  4. To assess the correlation between variables derived from three autonomic function tests- Baroreceptor sensitivity(BRS),Heart rate variability(HRV) and Electrochemical skin conductance(ESC) with incidence of post induction hypotension.
  5. To evaluate the need and amount of vasopressor administration to correct hypotension

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age 18-80 years
  • Diagnosed with diabetes mellitus (type 1 or 2)
  • Undergoing elective non-cardiac surgery under general anaesthesia
  • ASA physical status I–III.

排除标准

  • Medications or diseases severely affecting Autonomic Nervous System (e.g., Parkinson’s disease, chronic atrial fibrillation)
  • Emergency surgeries
  • Patients with known cardiac disease.

结局指标

主要结局

To assess whether preoperative autonomic function tests can predict post induction

时间窗: To assess whether preoperative autonomic function tests can predict post induction | hypotension in diabetic patients undergoing elective surgeries under general anaesthesia which is done 1 or 2 days before surgery.

hypotension in diabetic patients undergoing elective surgeries under general anaesthesia

时间窗: To assess whether preoperative autonomic function tests can predict post induction | hypotension in diabetic patients undergoing elective surgeries under general anaesthesia which is done 1 or 2 days before surgery.

次要结局

  • 1. To determine the incidence of Post-Induction Hypotension (PIH), i.e. arterial hypotension after anaesthesia induction.(2. To determine the incidence of Early Intraoperative Hypotension (eIOH)post incision.)

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Arjun AL

Government Medical College and Hospital,Chandigarh

研究点 (1)

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