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CTRI Number  CTRI/2023/09/057348 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of change in perfusion index during induction of anaesthesia in normotensive & hypertensive patients 
Scientific Title of Study   Comparison of change in perfusion index during induction of anaesthesia in normotensive and hypertensive patients posted for elective surgery 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMohammad Kamran  
Designation  Post Graduate Student 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesiology and Intensive Care Ground Floor Main Operation Theatre Building Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi

New Delhi
DELHI
110029
India 
Phone  9971952560  
Fax    
Email  rockstar.mks@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amita Gupta 
Designation  Professor and Consultant  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesiology and Intensive Care Ground Floor Main Operation Theatre Building Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi

New Delhi
DELHI
110029
India 
Phone  9910382190  
Fax    
Email  amitaguptadr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrMohammad Kamran  
Designation  Post Graduate Student 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesiology and Intensive Care Ground Floor Main Operation Theatre Building Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi

New Delhi
DELHI
110029
India 
Phone  9971952560  
Fax    
Email  rockstar.mks@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital  
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE GROUND FLOOR MAIN OPERATION THEATRE BUILDING VMMC AND SAFDARJUNG HOSPITAL NEW DELHI 110029 
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 Mohammad Kamran   Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Anaesthesiology and Intensive Care Ground Floor Main Operation Theatre Building Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi South DELHI
New Delhi
DELHI 
9971952560

rockstar.mks@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Vardhman Mahavir Medical College and Safdarjung Hospital   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 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Asa 1 
 
ExclusionCriteria 
Details  Patients with anticipated difficult airway and any known respiratory pathology. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the change in perfusion index values in normotensive & hypertensive patients 5 minutes following administration of intravenous induction agent posted for elective surgery using pulse oximeter. 
Preinduction and 1,2,3,4,5,6,7,8,9,10 minutes after induction of anaesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the change in perfusion index values in normotensive & hypertensive adult patients in the first 10 minutes following induction of anaesthesia. 2. Perfusion index value correlation with non-invasive hemodynamic monitoring (SBP, DBP, MAP, HR) in normotensive & hypertensive patients following induction of anaesthesia.  1,2,3,4,5,6,7,8,9,10 minutes following induction of general anaesthesia  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   15/09/2023 
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   Perfusion index (PI) is a non-invasive numerical value of peripheral perfusion calculated using infrared spectrum as part of plethysmography waveform processing. It is a simple, cost-effective and non-invasive method of assessing peripheral perfusion determined by the percentage of pulsatile to non-pulsatile blood flow in the extremities that can be continuously and non-invasively obtained from pulse oximeter.
Patients with hypertension are exposed to hemodynamic instability during anaesthesia, which is known to be associated with adverse perioperative outcomes such as acute renal failure or cerebral ischemia. The cause of this hemodynamic instability is that patients with hypertension are exposed to high blood pressure for a long time, leading to anatomical or pathophysiological changes in the hemodynamic systems. These changes make them sensitive to the effects of anaesthetic drugs that frequently cause hypotension. Patients with hypertension may develop significant hypotension after the induction of anaesthesia when the initial sympathetic nervous system response to laryngoscopy and endotracheal intubation which typically increases blood pressure is subsided. Induction of anaesthesia and insertion of Laryngeal mask airway both induce clinically relevant hemodynamic changes in patients. PI reflects the patient’s haemodynamic state. Determining and monitoring the perfusion index pre and post induction helps to predict the haemodynamic instability and timely corrective measures to be applied Hypertensive patients are more prone to develop haemodynamic instability than those without hypertension. There are very few studies comparing the perfusion index in hypertensives and normotensive patients in general anaesthesia. The aim of this study is to compare the change of perfusion index in normotensive and hypertensive adult patients during induction of general anaesthesia posted for elective surgery.

 
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