| CTRI Number |
CTRI/2025/06/088514 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study to predict the change in perfusion index during Endotracheal intubation and extubation under General Anaesthesia. |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of perfusion index as a predictor of haemodynamic response at the time of endotracheal Intubation and extubation in elective surgery under General Anaesthesia : A prospective observational 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 |
Gagan Virk |
| Designation |
PG student |
| Affiliation |
Jhalawar Medical College and Hospital |
| Address |
Department of Anaesthesia, NH 12 KOTA ROAD JHALAWAR
Jhalawar
RAJASTHAN
326001
India |
| Phone |
8126295777 |
| Fax |
|
| Email |
virkgagan594@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Meena |
| Designation |
Professor |
| Affiliation |
Jhalawar Medical College and Hospital |
| Address |
Room no. 110, Department of Anesthesia, first floor S.R.G hospital, Jhalawar
Anaesthesia Department, Nh 12 , KOTA ROAD, Jhalawar
Jhalawar
RAJASTHAN
326001
India |
| Phone |
9461290011 |
| Fax |
|
| Email |
sunitameena98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Meena |
| Designation |
Professor |
| Affiliation |
Jhalawar Medical College and Hospital |
| Address |
Room no 101, First floor , Department of Anaesthesia, SRG hospital, Jhalawar
Anaesthesia Department, Nh 12 , KOTA ROAD, Jhalawar
Jhalawar
RAJASTHAN
326001
India |
| Phone |
9461290011 |
| Fax |
|
| Email |
sunitameena98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jhalawar medical college , Jhalawar , pin 326001 ,Rajasthan , India |
|
|
Primary Sponsor
|
| Name |
Gagan Virk |
| Address |
vill keshogarh, riccha, gadarpur, U.S Nagar , pin code 263152 uttarakhand, India |
| Type of Sponsor |
Other [self] |
|
|
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 Gagan virk |
Jhalawar medical college and hospital |
Department of Anaesthesiology, firstFloor roomno110,
Jhalawar
RAJASTHAN |
8126295777
virkgagan594@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee jhalawar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
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 |
Patients willing to give consent
BMI less than 30
ASA 1 and 2
Patients undergoing to elective surgery under general anesthesia and perform oral endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Patient with a history of sore throat or upper respiratory tract infection
Hemodynamically unstable patients
Pregnant women
Patients with a history of cardio-pulmonary disease, liver, or renal disorders and any chronic disease and history of drug allergy
Patients with anticipated and unanticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and compare the PI changes from baseline PI at different time intervals 1,2,3,4,5,10 min post intubation, start and end of Neuromuscular block, pre extubation and post extubation at 1,2,3,4,5 min. |
1,2,3,4,5,10 min post intubation and extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe & compare changes in hemodynamic parameters (HR, SBP,DBP, & MAP) from baseline hemodynamic parameters at different time intervals & any correlation with PI. |
1,2,3,4,5,10 min
|
| To assess & compare changes in the Rate pressure product (HR × SBP) at different time intervals from baseline rate pressure product |
1,2,3,4,5,10 min |
| To assess & compare of significant HR SBP DBP MBP & PI (increase HR more than 10 BPM, increase SBP & DBP more than 15mmhg, PI decrease in more than 10 percent) at different time intervals from baseline values of these parameters |
1,2,3,4,5,10 min |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
21/06/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 to evaluate and assess that ,Perfusion Index is used to detect hemodynamic stress response at different time intervals (1,2,3,4,5,10 min post intubation, start and end of Neuromuscular block, pre extubation and post extubation at 1,2,3,4,5 min). sample size of 50 participants undergoing general anesthesia is calculated with Inclusion and Exclusion criteria. Baseline parameters recorded , then parameters recorded during Intubation , at the time of reversal and extubation.All the data will be entered on to a micro soft excel spread sheet and analysed by using appropriate tests . |