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CTRI Number  CTRI/2025/07/091170 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Can pre surgery tests for detecting the function of nervous system which controls involuntary bodily functions predict low blood pressure after giving anaesthesia in diabetic patients undergoing planned surgeries. 
Scientific Title of Study   Preoperative autonomic function assessment as a predictor of post induction hypotension in diabetic patients undergoing elective surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arjun AL 
Designation  Junior Resident 
Affiliation  Government Medical College and Hospital,Chandigarh 
Address  Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH, Sector 32B ,Chandigarh,160030,India

Chandigarh
CHANDIGARH
160030
India 
Phone  8547490866  
Fax    
Email  alarjun70@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Richa Saroa  
Designation  Professor 
Affiliation  Government Medical College and Hospital,Chandigarh 
Address  Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH, Sector 32B ,Chandigarh,160030,India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121513  
Fax    
Email  richajayant@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjeev Palta 
Designation  Professor 
Affiliation  Government Medical College and Hospital,Chandigarh 
Address  Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH, Sector 32B ,Chandigarh,160030,India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121523  
Fax    
Email  sanjeev_palta@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive care,Block D,Level 5,Government Medical College and Hospital,Sector 32B,Chandigarh,India,pin code 160030 
Department of Physiology,Block E,Level 5,Government Medical College and Hospital,Sector 32B,Chandigarh,India,pin code 160030 
 
Primary Sponsor  
Name  Government Medical College and Hospital  
Address  Department of Anaesthesia and Intensive care,Block E,Level 5,Government Medical College and Hospital,Sector 32B,Chandigarh,India,pin code 160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arjun AL  Government Medical College And Hospital Chandigarh  Department of Anaesthesia and intensive care,Block D,Level 5,Government Medical College and Hospital,Sector 32B,Chandigarh,India,pin code 160030
Chandigarh
CHANDIGARH 		 8547490866

alarjun70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee,GMCH Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age 18-80 years
2. Diagnosed with diabetes mellitus (type 1 or 2)
3. Undergoing elective non-cardiac surgery under general anaesthesia
4. ASA physical status I–III 
 
ExclusionCriteria 
Details  1. Medications or diseases severely affecting Autonomic Nervous System (e.g.,
Parkinson’s disease, chronic atrial fibrillation)
2. Emergency surgeries
3. Patients with known cardiac disease  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess whether preoperative autonomic function tests can predict post induction
hypotension in diabetic patients undergoing elective surgeries under general anaesthesia 		 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. 
 
Secondary Outcome  
Outcome  TimePoints 
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.
3. To evaluate the need and amount of vasopressors used to correct hypotension.  		 1. To determine the incidence of Post-Induction Hypotension (PIH), i.e. arterial hypotension
occurring during the first 20 min after anaesthesia induction.
2. To determine the incidence of Early Intraoperative Hypotension (eIOH), i.e., arterial
hypotension up to 30 minutes post incision.
3. To evaluate the need and amount of vasopressors used to correct hypotension after anaesthesia induction upto 30 mins 
 
Target Sample Size   Total Sample Size="214"
Sample Size from India="214" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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


 
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