| CTRI Number |
CTRI/2023/12/060922 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the changes in diameter of the vein in the neck , to see if it changes after spinal anesthesia and to predict hypotension after spinal anesthesia |
|
Scientific Title of Study
|
Ultrasonic evaluation of the internal jugular vein to predict post spinal hypotension in pregnant women undergoing elective cesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumaiya Nayab |
| Designation |
Junior Resident(Acad) |
| Affiliation |
All India Institute of Medical Science, Bibinagar |
| Address |
Dept. of Anesthesiology,All India Institute of Medical Science, Bibinagar, Hyderabad Metropoloitan region, Telangana, Hyderabad
Hyderabad
TELANGANA
508126
India |
| Phone |
7903439578 |
| Fax |
|
| Email |
snayab04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Kalyani Surya Dhana Lakshmi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science, Bibinagar |
| Address |
Dept. of Anesthesiology,All India Institute of Medical Science, Bibinagar, Hyderabad Metropoloitan region, Telangana, Hyderabad
Hyderabad
TELANGANA
508126
India |
| Phone |
7893720606 |
| Fax |
|
| Email |
skdhanalakshmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Kalyani Surya Dhana Lakshmi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science, Bibinagar |
| Address |
Dept. of Anesthesiology,All India Institute of Medical Science, Bibinagar, Hyderabad Metropoloitan region, Telangana, Hyderabad
Hyderabad
TELANGANA
508126
India |
| Phone |
7893720606 |
| Fax |
|
| Email |
skdhanalakshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science , Bibinagar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science Bibinagar |
| Address |
All India Institute of Medical Science Bibinagar Hyderabad Metropolitan Region Telangana |
| 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 |
| SUMAIYA NAYAB |
All India Institute of Medical Science, BIBINAGAR |
Department of Anaesthesiology All India Institute of Medical Science Bibinagar Hyderabad Metropolitan Region Telangana
508126
India
Hyderabad
TELANGANA |
7903439578
snayab04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(AIIMS BBN-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant fenale, weight 45-70 kg, age 20-35 years,
height 145-165 cm, BMI< 30, hemoglobin >10g/dl,
ASA 2, posted for elective cesarean sections. |
|
| ExclusionCriteria |
| Details |
Patient refusal, emergency surgeries, ASA grade 3,4, active hepatic , renal, cardiovascular, respiratory, or neurological disease, known bleeding diathesis, neuromuscular disease, local skin infection, contraindication to neuraxial anesthesia, BMI>30kg/m2, allergy to any of the study meication, placenta previa, placenta accreta, any change of plan of anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hypotension |
After giving spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in internal jugular vein diameters |
changing position from supine to left lateral position |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
10/01/2024 |
| 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="2"
Months="0"
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
|
Hypotension is one of the major side affects of spinal anaesthesia. This hypotension in cesarean sections may lead to adverse outcomes such as decreased utero placental blood flow leading to fetal hypoxia and bradycardia. So by ultrasonic evaluation of internal jugular vein if we are able to check the volume status of the mother and predict post spinal hypotension, it will help us to take timely action to prevent hypotension, in turn prevent episodes of post spinal hypotension. |