| CTRI Number |
CTRI/2024/11/076651 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Axillary vein diameter in predicting spinal anaesthesia induced hypotension |
|
Scientific Title of Study
|
Axillary vein collapsibility index and diameter in predicting spinal anaesthesia induced hypotension in patient undergoing lower abdominal surgery A cross section 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 |
DrArshy Parveen Mansoori |
| Designation |
PG student |
| Affiliation |
ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi |
| Address |
Department of Anesthesia,ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi
New Delhi
DELHI
110015
India |
| Phone |
7770944245 |
| Fax |
|
| Email |
Doctormiraki786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad CGS |
| Designation |
Professor and HOD |
| Affiliation |
ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi |
| Address |
Department of Anesthesia,ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi
New Delhi
DELHI
110015
India |
| Phone |
9480616548 |
| Fax |
|
| Email |
prasad_cgs@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad CGS |
| Designation |
Professor and HOD |
| Affiliation |
ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi |
| Address |
Department of Anesthesia,ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi
New Delhi
DELHI
110015
India |
| Phone |
9480616548 |
| Fax |
|
| Email |
prasad_cgs@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi,India,110015 |
|
|
Primary Sponsor
|
| Name |
Dr Arshy Parveen Mansoori |
| Address |
Department of Anesthesia,ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi,India,110015 |
| 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 Prasad CGS |
ESIC - PGIMSR and Hospital, Basaidarapur, New Delhi |
Department of Anesthesia,old building,second floor OT
New Delhi
DELHI |
9480616548
prasad_cgs@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Sonia Khattar Member Secretary - IEC PGIMSR BASAIDARAPUR |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade 1/2
2.Patient undergoing lower abdominal surgery under spinal anestesia |
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Contraindication to spinal anesthesia
3.Patients on ACE inhibitors
4.Patients with systolic BP < 100mmhg or Mean BP <65mmhg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of preoperative axillary vein diameter and collapsibility index with the patient, who develops spinal anesthesia induced hypotension |
8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree of hypotension, number of patient develops hypotension, vasopressors and fluid requirement |
1 year |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
21/11/2024 |
| 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="6"
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
|
Axillary vein collapsibility index and diameter in predicting spinal anaesthesia induced hypotension in patient undergoing lower abdominal surgery : A prospective observational study
Here we do preoperative measurement of axillary vein collapsibility index and diameter, and we give spinal anesthesia to patient intraop , and observe for hypotension till 30 min of giving spinal and we correlate it with axillary vein collapsibility index | |
|