| CTRI Number |
CTRI/2025/07/091954 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Radiological] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Assessing central venous collapsibility for predicting hypotension in patients undergoing spinal anaesthesia |
|
Scientific Title of Study
|
CENTRAL VENOUS COLLAPSIBILITY: A NOVEL PREDICTOR OF POST-SPINAL HYPOTENSION SEVERITY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Agathiyan A |
| Designation |
Postgraduate |
| Affiliation |
srm medical college |
| Address |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894280868 |
| Fax |
|
| Email |
agathiyananbu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saravanan C R |
| Designation |
Professor |
| Affiliation |
srm medical college |
| Address |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
drcrsaravanan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saravanan C R |
| Designation |
Professor |
| Affiliation |
srm medical college |
| Address |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India
TAMIL NADU
603203
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
drcrsaravanan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Agathiyan A |
| Address |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Saravanan C R |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saravanan C R |
srm medical college |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU |
9884001153
drcrsaravanan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
IJV |
To assess the Collapsiblity index of IJV before administering spinal anaesthesia. |
| Comparator Agent |
IVC |
To assess the Collapsiblity index of IVC before administering spinal anaesthesia. |
| Intervention |
SCV |
To assess the Collapsiblity index of SCV before administering spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years
ASA PS 1-2
Patients undergoing spinal anaesthesia with fixed drug volume
of 15mg of 0.5% (H) bupivacaine
Surgeries done in supine position
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Contraindications to regional nerve block
Coagulopathy
Cellulitis or infection at the local site
Allergy to local anaesthetic drugs
Patients with pre existing nerve injury
Failed spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the sensitivity, specificity, and predictive values of IJV, SCV, and IVC collapsibility indices in predicting Post spinal hypotension with in 30 mins of spinal anesthesia. |
To compare the sensitivity, specificity, and predictive values of IJV, SCV, and IVC collapsibility indices in predicting Post spinal hypotension with in 30 mins of spinal anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation between IJV, SCV, & IVC collapsibility indices & the severity of Post spinal hypotension with in 30 mins of spinal anesthesia. |
To evaluate the correlation between IJV, SCV, & IVC collapsibility indices & the severity of Post spinal hypotension with in 30 mins of spinal anesthesia. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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="0"
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
|
•
Patients
will be hospitalized the day before surgery and instructed to
fast from midnight.
•
Anesthesia
examination will be conducted the night before surgery.
•
Regular hemodynamic monitoring will be
done to know the baseline values,
-Three-lead
electrocardiography
-Pulse oximetry
-Non-invasive blood pressure measurement
•
On the day of surgery , patient will be
received in premedication room.
•
IJV
,SCV and IVC
measurements will be taken using a Sonosite M-turbo ultrasound machine.
•
IJV
measurements will be taken using a linear vascular transducer (7-13 MHz,
38 mm).
•
SCV measurements will be
taken using a linear vascular transducer (7-13 MHz, 38 mm).
•
IVC
measurements will be taken using a curvilinear USG probe (1-5 MHz, 21 mm).
•
All the Measurements will be recorded
for three respiratory cycles.
•
IJVCI,
SCVCI and IVCCI will be
calculated using the same equation: (Maximum diameter - Minimum diameter) /
Maximum diameter) x 100%.
•
After which patient will be shifted inside
the OT and the monitors will be attached.
•
Spinal
anesthesia will be
administered with 0.5% hyperbaric bupivacaine at
a fixed dose of 15mg.
•
Patients
will
receive a co-load of Ringer lactate solution.
•
Sensory
block was monitored, and surgery was initiated when the block reached the T6
level.
•
Heart
rate and mean arterial pressure (MAP) will be recorded every 3 minutes for the first 20 minutes.
•
Ephedrine
will
be used to treat hypotension,
and atropine will be
used to treat bradycardia.
|