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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
|
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.
|