| CTRI Number |
CTRI/2021/03/032143 [Registered on: 19/03/2021] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
role of inferior vena cava diameter measurement using ultrasound in predicting fall in blood pressure after spinal anesthesia in patients undergoing cesarean section |
|
Scientific Title of Study
|
Role of inferior vena cava sonography in predicting hypotension after spinal anesthesia in term patients undergoing cesarean section.An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mithun R |
| Designation |
Postgraduate Trainee |
| Affiliation |
All India institute of medical science patna |
| Address |
Department of Anesthesia
All india institute of Medical Sciences , Phulwari Sharif ,Patna ,Bihar
Patna
BIHAR
801507
India |
| Phone |
9750074235 |
| Fax |
|
| Email |
rathinasamymithun@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Sahay |
| Designation |
Additional professor |
| Affiliation |
All India institute of medical science patna |
| Address |
Department of Anesthesia
All india institute of Medical Sciences , Phulwari Sharif ,Patna ,Bihar
Patna
BIHAR
801507
India |
| Phone |
9431184516 |
| Fax |
|
| Email |
nishantsahay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mithun R |
| Designation |
Postgraduate Trainee |
| Affiliation |
All India institute of medical science patna |
| Address |
Department of Anesthesia
All india institute of Medical Sciences , Phulwari Sharif ,Patna ,Bihar
Patna
BIHAR
801507
India |
| Phone |
9750074235 |
| Fax |
|
| Email |
rathinasamymithun@gmail.com |
|
|
Source of Monetary or Material Support
|
| all india institute of medical sciences , patna |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA |
| Address |
N.H.98, Phulwarisharif, AIIMS Patna |
| 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 Mithun R |
All India Institute of Medical Sciences |
Department of Anesthesiology, Phulwarisharif , Patna
Patna
BIHAR |
9750074235
rathinasamymithun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Term pregnancy with singleton fetus.
2. Patient undergoing caesarean section under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Complicated pregnancy with co-morbidities eg GDM, Pregnancy Induced Hypertension
2. Patients undergoing cesarean section under general anaesthesia.
3. Women with twins or multiple pregnancy
4. Patients already hemodynamically unstable
5.Patients who refused
6.Category 1 LSCS
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare whether IVC Collapsibility index in left lateral 20 degree is better in predicting hypotension following spinal anesthesia, as compared to supine tilt in term patients undergoing cesarean section. |
For the first 20minutes after spinal anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the amount of intraoperative vasopressors usage.
2. To determine the amount of intraoperative fluids usage
|
nil |
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
Final Enrollment numbers achieved (Total)= "172"
Final Enrollment numbers achieved (India)="172" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/03/2021 |
| Date of Study Completion (India) |
11/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fluid management in an obstetric patient is a challenging task for the
clinicians as both hypovolemia and volume overload increase morbidity and
mortality. Pregnant women with predelivery hypovolemia are at risk of
cardiovascular collapse and the sympathetic blockade may severely decrease
venous return.Transabdominal USG measurements of inferior vena cava (IVC) are
noninvasive and thus are associated with minimal complications.Sonographic measurements of the inferior vena cava which predict hypovolemia
and fluid responsiveness could, as a result, help in prediction and thus
prevention of post spinal hypotension which is of immense clinical
significance. We are expecting that with the help of IVC
collapsibility index we are able to predict hypotension after spinal
anesthesia.We may reduce the occurrence of post spinal hypotension and other
hemodynamic fluctuations. We can guide our fluid administration based upon IVC collapsibility
index and thus prevent hyper-hydration too. |