| CTRI Number |
CTRI/2025/05/086996 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
To predict hypotension after spinal anaesthesia with ultasonography |
|
Scientific Title of Study
|
Usefulness of ultrasonographic measurement of inferior vena cava collapsibility index and caval aorta index to predict hypotension after spinal 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 |
Aparna Chandrasekhar |
| Designation |
Junior Resident |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Anesthesiology
JSS Hospital
Mysore
Karnataka
Mysore
KARNATAKA
570004
India |
| Phone |
9496389390 |
| Fax |
|
| Email |
aparnanairacs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana K N |
| Designation |
Professor and Head of the department |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department Of Anesthesiology
JSS Hospital
Mysore
Karnataka
Mysore
KARNATAKA
570004
India |
| Phone |
9845140637 |
| Fax |
|
| Email |
drarchanakashi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana K N |
| Designation |
Professor and Head of the department |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Anesthesiology
JSS Hospital
Mysore
Karnataka
KARNATAKA
570004
India |
| Phone |
9845140637 |
| Fax |
|
| Email |
drarchanakashi@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Medical college and hospital
Mysore
Karnataka
INDIA
570004 |
|
|
Primary Sponsor
|
| Name |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
JSS MEDICAL COLLEGE AND HOSPITAL
MYSORE
KARNATAKA
INDIA
570004 |
| Type of Sponsor |
Private 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 |
| Aparna Chandrasekhar |
JSS MEDICAL COLLEGE AND HOSPITAL |
Patients of ORTHOPAEDICS, GENERAL SURGERY, GASTROSURGERY, PLASTIC SURGERY, ONCOSURGERY, UROLOGY, posted for elective surgery under spinal anesthesia, OT complex, JSS HOSPITAL,
MG ROAD
AGRAHARA
MYSORE
KARNATAKA
Mysore
KARNATAKA |
9496389390
aparnanairacs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH,INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Non obstetric and non vascular surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
Spinal anomalies
Any contraindication for spinal anaesthesia - infection at the site of injection, raised intracranial pressure, deranged coagulation profile, drug allergy
ASA 3 and above
BMI more than 30kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict the occurrence of HYPOTENSION in patients with an INFERIOR VENA CAVA COLLAPSIBILITY IMDEX more than or equal to 50 percent and CAVAL AORTA INDEX more than 1 using ULTRASONOGRAPHY in patients undergoing infraumbilical surgeries |
every 2 MINUTES till 30 MINUTES after spinal anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine whether USG guided INFERIOR VENA CAVA COLLAPSIBILITY INDEX or CAVAL AORTA INDEX a better parameter to predict POST SPINAL ANESTHESIA HYPOTENSION
To predict efficacy of Inferior vena cava collapsibility index AND CAVAL aorta index over PERFUSION INDEX to predict post spinal anesthesia hypotension |
every 2 MINUTES immediately after spinal anesthesia till 30 MINUTES |
|
|
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)
|
30/05/2025 |
| 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="6"
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
|
After obtaining Ethical Committee approval and written informed consent from patients of ASA I-II physical status of age 18-50years of either sex undergoing elective non obstetrical and non vascular infraumbilical surgeries are selected for the study. |