| CTRI Number |
CTRI/2025/04/084648 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
"Comparing Brain Blood Flow Parameters During C-Section in Women with and without Preeclampsia under Spinal Anaesthesia" |
|
Scientific Title of Study
|
Comparison of Cerebral Haemodynamics using Transcranial Doppler during Caesarean Delivery under Spinal anaesthesia between Preeclamptic and Normotensive parturients: 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 |
Kanishk Arora |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anesthesiology and Critical care AIIMS bathinda
Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
7982586452 |
| Fax |
|
| Email |
kanishkarora98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Grewal |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anesthesiology and Critical care AIIMS bathinda
Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9815482626 |
| Fax |
|
| Email |
dranjugrewal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank Paliwal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anesthesiology and Critical care AIIMS bathinda
Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8451858199 |
| Fax |
|
| Email |
shashankupaliwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bathinda Mandi Dabwali Road, Bathinda Punjab- 151001 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Kanishk Arora |
All India Institute of Medical Sciences, Bathinda |
Anesthesia department
First floor, OT complex, D block, OPD building
Bathinda
Punjab
Bathinda
PUNJAB |
7982586452
-
kanishkarora98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O149||Unspecified pre-eclampsia, (2) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Female |
| Details |
1. Normotensive and Preeclamptic parturients with Gestational week 32 and above
2. ASA ( American Society of Anaesthesiologists) physical class II-III
3. Caesarean delivery under Spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Neurologic, cardiac disease, chronic hypertension, diabetes mellitus or pulmonary disease
2. Urgent category 1 [NICE GUIDELINES ] caesarean delivery due to severe fetal bradycardia, abruptio placenta, cord prolapse or massive haemorrhage, and coagulopathy
3. Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in cerebral haemodynamics (Middle Cerebral Artery Mean Flow Velocity, Pulsatility Index, Resistance Index, Estimated Cerebral perfusion pressure) in Preeclamptic and Normotensive Parturients under Spinal Anaesthesia. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate 48- hours Post-delivery cerebral haemodynamics .
2.To evaluate correlation between blood pressure and cerebral haemodynamics.
|
postoperative - 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
15/04/2025 |
| 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="1"
Months="6"
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
|
This study aims to evaluate changes
in cerebral haemodynamics in Preeclamptic and Normotensive Parturients under
Spinal Anaesthesia
1.Patient
Enrolment Criteria
Inclusion
and exclusion criteria applied.
Written
informed consent obtained
2.Preoperative
Assessment
Demographic data collected.
Indications for cesarean delivery noted.
Preoperative medications recorded.
Laboratory values measured.
Neurological and systemic symptoms documented.
3.ASA Standard Monitors attached
4.Middle
Cerebral Artery (MCA) Identification MCA
identified using 2MHz-pulsed TCD probe. Headframe
placed for continuous monitoring.
5.Baseline Measurement Three measurements taken at 1-minute intervals before anesthesia. Average score recorded as baseline value.
6.Intraoperative Monitoring
7. Measurements repeated at
specified intervals after spinal injection
8. Additional reading taken
after removal of placenta
9. Parameters monitored
continuously until end of operation.
10.Any significant change
>20% from the baseline in
any parameters will also be recorded
|