| CTRI Number |
CTRI/2023/10/058279 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A observational study to predict the incidence of hypotension that develops after spinal anaesthesia |
|
Scientific Title of Study
|
Pre operative ultrasonographic evaluation of inferior vena cava collapsibility index, internal jugular vein collapsibility index and aorto caval index in prediction of hypotension following spinal anesthesia in patients undergoing elective infra umbilical surgeries-a prospective single blinded 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 |
Ameerunnisha begum |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
LD 001 Department of Anaesthesiology
Saveetha medical college and hospital
Thandalam chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9629804469 |
| Fax |
|
| Email |
doctr.nisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surya R |
| Designation |
Associate professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesiology
Saveetha medical college and hospital
Thandalam chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8489177972 |
| Fax |
|
| Email |
suryaratnasamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ameerunnisha begum |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
LD 001,department of Anaesthesiology
Saveetha medical college and hospital
Thandalam,
Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9629804469 |
| Fax |
|
| Email |
doctr.nisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital
Thandalam
Chennai 602105
|
|
|
Primary Sponsor
|
| Name |
Ameerunnisha begum |
| Address |
Post graduate
Department of Anaesthesiology and pain medicine
Saveetha medical college and hospital
Thandalam
Chennai |
| 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 Ameerunnisha begum |
Saveetha medical college and hospital |
Department of Anaesthesiology Saveetha medical college and hospital Saveetha nagar
Thandalam
Chennai
Chennai
TAMIL NADU |
9629804469
doctr.nisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Coming for elective infra umbilical surgeries under spinal anaesthesia |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
With ASA PHYSICAL STATUS 1 and 2 scheduled for elective infra umbilical surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
BMI>30kg/m2
On ACE inhibitors
Pregnant Women
Emergency cases
Patients whose baseline arterial SBP<90mmHg
Or MAP<70 mmHg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the inferior venacava collapsibility index, internal jugular vein collapsibility index & aorto caval index with the help of an ultrasound,preoperatively in people undergoing elective infra umbilical surgeries for prediction of post spinal hypotension |
Base line
5 minutes after spinal anaesthesia
10 minutes after spinal anaesthesia
Every 5 minutes till the first 60 minutes after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess which is the better predictor of hypotension among the three variables |
Every 5 minutes for the first 60 minutes post spinal anaesthesia
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/10/2023 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 with a sample size of 100 to be conducted in Saveetha Medical college and Hospital for a period of 12 months.The aim of this study is to assess the inferior venacava collapsibility index, internal jugular vein collapsibility index and aorto caval index with the help of an ultrasound,preoperatively in people undergoing elective infra umbilical surgeries for prediction of post spinal hypotension and to analyze the requirement of fluid resuscitation and vasopressors for the same. |