| CTRI Number |
CTRI/2024/09/073840 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the efficacy of caval aorta index and inferior vena cava collapsibility index on the incidence of hypotension after spinal anesthesia in adult patients. |
|
Scientific Title of Study
|
Predictive efficacy of caval aorta index and inferior vena cava collapsibility index on incidence of hypotension after subarachnoid block in adult patients undergoing infraumbilical surgeries. |
| 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 BhanujaB |
| Designation |
PG Resident |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
Delhi, 110029,India.
New Delhi
DELHI
110029
India |
| Phone |
7483388621 |
| Fax |
|
| Email |
bhanujab9535@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Gupta |
| Designation |
Consultant and Professor |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
Delhi, 110029,India.
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Gupta |
| Designation |
Consultant and Professor |
| Affiliation |
Mahavir |
| Address |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
Delhi, 110029,India.
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman Mahavir Medical College and Safdarjung Hospital , New Delhi , Delhi 110029 , India |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, New Delhi,Delhi 110029 India |
| Type of Sponsor |
Government 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 |
| Dr Bhanuja B |
VMMC and Safdarjung Hospital |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi, Delhi ,110029, India
New Delhi
DELHI |
7483388621
bhanujab9535@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and Safdarjung Hospital Institutional Ethics Committee |
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 |
Caval aorta index and inferior vena cava collapsibility index |
Efficacy of caval aorta index and inferior vena cava collapsibility index in predicting hypotension after subarachnoid block in Adult patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I&II Undergoing elective infraumbilical surgery under spinal anaesthesia in supine position |
|
| ExclusionCriteria |
| Details |
1. Contraindications for spinal Anesthesia
2.Patients with pre existing Hypotension
3. Pregnency
4 Body mass index more than 30 kg per meter square |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the sensitivity and specificity of caval aorta index and inferior vena cava collapsibility index as predictor of hypotension after subarachnoid block in adult patients undergoing infraumbilical surgeries. |
Every 1min till 5 min & every 2 min till 15 min & every 5min until 60 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the predictive value of caval aorta index & inferior vena cava collapsibility index as predictor of hypotension after subarachnoid block |
Every 1min till 5 min & every 2 min till 15 min & every 5min until 60 min |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
01/10/2024 |
| 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="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
|
AIM
To study the predictive efficacy of caval aorta index and inferior vena cava collapsibility index as predictor of hypotension after subarachnoid block in adult patients undergoing infraumbilical surgeries.
FLOW CHART OF METHODOLOGY
In pre Operative Room - Pre anesthetic evaluation
- NPO 6hrs
- Written informed consent
- HR ,NIBP,Spo2 noted
|
- Measurement of IVC internal anteroposterior diameter IVCD max(during expiration)& IVCD min(during inspiration)
- Measurement of maximum internal diameter of Abdominal aorta (during systole)
|
In Operation theatre | Baseline Heart rate , NIBP, Spo2 noted |
- Spinal Anesthesia in a sitting position at L3-L4 intervertebral space
- A dose of 2.8ml of 0.5% hyperbaric bupivacaine + 10mcg fentanyl through 25- gauge Quincke spinal needle
- Patients will be kept supine position
|
| Rapid IV co- loading with 10 ml/ kg / hr Ringer lactate after giving Spinal anaesthesia |
| NIBP, HR, and Spo2 will be recorded every 1 minute till 5 min and every 2 min till 15 min and then every 5 min until 60 min since the administration subarachnoid block had passed. |
|