| CTRI Number |
CTRI/2025/03/082139 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To check if certain ultrasound parameters in the neck artery can predict fall in blood pressure in pregnant women undergoing cesarean by spinal anesthesia |
|
Scientific Title of Study
|
Clinical utility of preoperative bilateral carotid artery corrected flow time (FTc) and carotid artery pulsatility index(PI) for predicting hypotension after spinal anesthesia in parturient undergoing elective caesarean section in tertiary care hospital |
| 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 Sugandha |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry.
Pondicherry PONDICHERRY 605006 India |
| Phone |
7018773232 |
| Fax |
|
| Email |
drsu4u@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vishnu Narayanan M R |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry.
Pondicherry PONDICHERRY 605006 India |
| Phone |
8547442182 |
| Fax |
|
| Email |
vishnu.narayanan.1993@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sugandha |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry.
Pondicherry PONDICHERRY 605006 India |
| Phone |
7018773232 |
| Fax |
|
| Email |
drsu4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry,605006 |
|
|
Primary Sponsor
|
| Name |
Dr Sugandha |
| Address |
Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry,605006 |
| 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 Sugandha |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Anaesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER),JIPMER campus road, Gorimedu, Dhanvantari Nagar, Puducherry 605006 Pondicherry PONDICHERRY |
7018773232
drsu4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee Jipmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All ASA Physical Status II Parturients with singleton pregnancy undergoing elective caesarean section under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1.Parturient not fit for Spinal Anesthesia
2.Parturient who has cardiovascular conditions like hypertension, arrhythmias, valvular heart disease, or other significant cardiac conditions
3.Parturient with pregnancy-induced hypertension disorder.
4.Parturient on medications that affect cardiovascular function (e.g. beta-blockers, vasodilators, prophylactic vasopressors)
5.Parturient with Carotid stenosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prediction of post spinal hypotension in pregnant women undergoing cesarean by measuring corrected flow time and pulsatility index of carotid artery |
Carotid artery ultrasound measurements will be done preoperatively and maternal hemodynamic parameters will be measured from baseline to delivery of the baby in every 1 minute interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the relationship between preoperative carotid corrected flow time (FTc) & pulsatility index(PI) with post spinal hypotension index among parturients undergoing elective lower segment caesarean section in tertiary care hospital |
Carotid artery ultrasound measurements will be done preoperatively & maternal hemodynamic parameters will be measured from baseline to delivery of the baby in every 1 minute interval |
|
|
Target Sample Size
|
Total Sample Size="310" Sample Size from India="310"
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)
|
09/04/2025 |
| 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="2" Months="0" 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
|
The parturient scheduled for an elective cesarean section under spinal
anesthesia will be recruited after obtaining informed and written consent one
day prior to surgery. After being transferred to the operating room, standard
ASA monitors will be attached to the parturient. Baseline values of heart rate,
systolic blood pressure, diastolic blood pressure, and mean arterial pressure
will be recorded with the table in a left lateral tilt at 15-20 degrees. A
high-frequency linear ultrasound probe will be placed over the common carotid
artery, approximately 2 cm proximal to the carotid bifurcation, to obtain
Doppler waveforms. These measurements will be taken with the table in a left
lateral tilt at 15-20 degrees. The data obtained from each side will be used to
calculate the corrected flow time interval (FTc) and pulsatility index (PI).Following the ultrasound assessments, the
parturient will be positioned for spinal anesthesia, and 0.5% hyperbaric
bupivacaine (1.8-2 ml) will be administered. The parturient will then be turned
supine with a wedge placed under the right hip. The level of sensory block will
be confirmed by the response to cold touch. Systolic blood pressure will be
measured at one-minute intervals after spinal anesthesia until the delivery of
the baby. Hypotension will be defined as a decrease in systolic blood pressure
to less than 100 mmHg or a fall of more than 80% from baseline. Any hypotension
will be treated with intravenous vasopressors, and the details of the treatment
will be recorded. The obtained data will be analyzed to identify any
correlation with post-spinal hypotension. |