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CTRI Number  CTRI/2024/07/070129 [Registered on: 07/07/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Prediction of fall in blood pressure using Perfusion index following general anaesthesia in patients undergoing elective surgery 
Scientific Title of Study   Perfusion index as a predictor of hypotension following intravenous induction of General Anaesthesia in patients undergoing elective surgery– A prospective observational cohort study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dipali Taneja 
Designation  Grade-1 Specialist 
Affiliation  Deen Dayal Upadhyay Hospital, Hari Nagar, New delhi 
Address  Department of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi

South West
DELHI
110064
India 
Phone  9718990125  
Fax    
Email  taneja.sandeep13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipali Taneja 
Designation  Grade-1 Specialist 
Affiliation  Deen Dayal Upadhyay Hospital, Harinagar, New delhi 
Address  Department of anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi

South West
DELHI
110064
India 
Phone  9718990125  
Fax    
Email  taneja.sandeep13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jawhar alavi 
Designation  DNB resident 
Affiliation  Deen Dayal Upadhyay Hospital, Harinagar, New delhi 
Address  Department of Anaesthesiology, Deen Dayal Upadhyay Hospital Shaheed Mangal Pandey Marg, Nanak Pura, Hari Nagar, New Delhi

South West
DELHI
110064
India 
Phone  8089240830  
Fax    
Email  jawhar.alavi@gmail.com  
 
Source of Monetary or Material Support  
Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi-110064 
 
Primary Sponsor  
Name  Deen Dayal Upadhyay Hospital 
Address  Shaheed Mangal Pandey Marg, Nanak Pura, Hari Nagar, New Delhi, Pin:110064 
Type of Sponsor  Research institution and hospital 
 
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 Jawhar alavi  Deen Dayal Upadhyay  Main Operation Theatre, 2nd Floor, Department of Anaesthesiology, Hari Nagar, New Delhi, Pin:110064
South West
DELHI 		 8089240830

jawhar.alavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee-Deen Dayal Upadhyay Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for elective surgery under general anaesthesia
2. ASA Physical status I of either Sex
3. Age between 18 and 60 years
4. Body Mass Index between 18.5 and 24.9 
 
ExclusionCriteria 
Details  Pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine sensitivity and specificity of baseline PI in predicting Hypotension (based on SBP and MAP) at 3 minutes following Intravenous Induction of General Anaesthesia in patients undergoing
Elective Surgery 		 To determine sensitivity and specificity of baseline PI in predicting Hypotension (based on SBP and MAP) at 3 minutes following Intravenous Induction of General Anaesthesia in patients undergoing
Elective Surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To determine Perfusion Index and Non-Invasive Haemodynamic parameters (HR, SBP, DBP, MAP) post intravenous induction in patients undergoing Elective Surgery under General Anaesthesia  0,1,2,3 minutes 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   20/07/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This is a Prospective observational study evaluating perfusion index as a predictor of hypotension following intravenous induction of General anaesthesia in patients undergoing elective surgery. In this study, 160 patients eligible under inclusion criteria will be included after obtaining consent. Perfusion index, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure, Heart rate will be recorded from baseline (before IV induction of general anaesthesia) every minute till 3 minutes before laryngoscopy and intubation. Statistical analysis will be done to determine sensitivity, Specificity, Positive predictive value, Negative predictive value for Baseline perfusion index in predicting hypotension (based on SBP and MAP) at 3 minutes following Intravenous induction of general anaesthesia. Study assess perfusion index as a predictor of hypotension following intravenous induction of General anaesthesia in patients undergoing elective surgery.
 
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