| CTRI Number |
CTRI/2024/07/071515 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The relation between the Baseline Perfusion Index and the Incidence of Hypotension in Patients undergoing Lower Abdominal Surgery under Spinal Anesthesia |
|
Scientific Title of Study
|
Evaluation of the Correlation between the Baseline Perfusion Index and the Incidence of Hypotension in Patients undergoing Lower Abdominal Surgery under Subarachnoid Block – A Prospective Observational Comparative 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 Bhavna saxena |
| Designation |
Senior Medical Officer |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Dept. of Anaesthesiology,Deen Dayal Upadhyay Hospital,Hari Nagar,New Delhi
Dept. of Anaesthesiology,Deen Dayal Upadhyay Hospital,Hari Nagar,New Delhi
West
DELHI
110064
India |
| Phone |
9718990124 |
| Fax |
|
| Email |
drbhavnasaxena2109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna saxena |
| Designation |
Senior Medical Officer |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Dept. of Anaesthesiology,Deen Dayal Upadhyay Hospital,Hari Nagar,New Delhi
Dept. of Anaesthesiology,Deen Dayal Upadhyay Hospital,Hari Nagar,New Delhi
DELHI
110064
India |
| Phone |
9718990124 |
| Fax |
|
| Email |
drbhavnasaxena2109@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavna saxena |
| Designation |
Senior Medical Officer |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Dept. of Anaesthesiology,Deen Dayal Upadhyay Hospital,Hari Nagar,New Delhi
Dept. of Anaesthesiology,Deen Dayal Upadhyay Hospital,Hari Nagar,New Delhi
DELHI
110064
India |
| Phone |
9718990124 |
| Fax |
|
| Email |
drbhavnasaxena2109@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology,Deen Dayal Upadhyay Hospital,Hari Nagar,New Delhi,pin code-110064 |
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay HospitalHari NagarNew Delhi |
| Address |
main ot-2,trauma ot,DDUH,New Delhi,pin code-110064,INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rashmijit Behera |
Deen Dayal Upadhay Hospital |
Main ot-2,trauma ot
Deen Dayal Upadhyay Hospital,
Harinagar
West
DELHI |
8093319813
rjbindash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee-Deen Dayal Upadhyay Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
this is a observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Lower abdominal surgeries
2 Age 18-60 years
3 ASA physical status I and II
|
|
| ExclusionCriteria |
| Details |
1 Severe respiratory disease
2 Cardiac disease
3 Obesity(BMI>25)
4 Uncontrolled hypertension
5 Peripheral vascular disease
6 Height less than 150 cm
7 Patient exceeding maximum MABL |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of hypotension in two groups with different baseline perfusion indices after subarachnoid block in patients undergoing lower abdominal surgery. |
0,2,4,6,8,10,12,14,16,18,20,25,30,35,40,45,50,55,60 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Response of Perfusion Index to mephentermine bolus & noradrenaline if given during hypotension |
0,2,4,6,8,10,12,14,16,18,20,25,30,35,40,45,50,55,60 min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
09/08/2024 |
| 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
|
It is a prospective observational comparative cohort study to know the correlation between the incidence of hypotension and baseline perfusion index in patients undergoing lower abdominal surgery under subarachnoid block.Here we see the perfusion index in 0,2,4,6,8,10,12,14,16,18,20,25,30,35,40,45,50,55,60 mins after giving spinal and if blood pressure falls map below 20% then we ll give vasopressor and check perfusion index after 1 min. Increase in perfusion index where Blood pressure will fall due to vasodilation. |