| CTRI Number |
CTRI/2025/09/094720 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
IJV collapsibility index for prediction of hypotension due to spinal anaesthesia |
|
Scientific Title of Study
|
Internal Jugular Vein Ultrasonography For Prediction
Of Post Spinal Hypotension In Patients Undergoing
Elective Total Abdominal Hysterectomy - 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 |
ASWATHY C B |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, KOZHIKODE |
| Address |
Department of Anaesthesiology
Government Medical College
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
7012857907 |
| Fax |
|
| Email |
aswathydeshmukh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineetha P |
| Designation |
Proffesor(CAP) |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology
Government Medical College
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9495930867 |
| Fax |
|
| Email |
dr.vineethasijin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shafna K T |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology
Government Medical College Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
8506911421 |
| Fax |
|
| Email |
shafnak87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college,
Kozhikode
Kerala, PIN 673008
India |
|
|
Primary Sponsor
|
| Name |
Aswathy C B |
| Address |
Sayoojyam(H)
KSHB
Medical college(p.o), Kozhikode PIN 673008
Kerala
India
KOZHIKODE
KERALA |
| 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 |
| ASWATHY C B |
Government medical college,kozhikode |
Department of Anaesthesiology
Kozhikode
kerala 673008
India
Kozhikode
KERALA |
07012857907
aswathydeshmukh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE KOZHIKODE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients scheduled for elective total abdominal hysterectomy surgery under spinal anaesthesia
2. American Society of Anaesthesiologists ( ASA )status 1 or 2
3. Height 150-165 cms
4. Volume of Bupivacaine used for SA should be in the range of 3-3.5 ml
|
|
| ExclusionCriteria |
| Details |
1. Absolute or relative contraindications or failure to perform spinal anaesthesia
2. Patients with uterine size more than 20 weeks
3. Obese patients (BMI=30 kg/m2) and ASA physical status 3 and above
4. Baselinesystolic pressure lessthan 110 mmtg or patients on ACE inhibitors/Diuretics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine preoperative ultrasonographic IJV measurements and
incidence of post spinal hypotension in terms of changes in systolic
BP and MAP in patients undergoing elective total abdominal
hysterectomy (TAH) under spinal anesthesia.
|
Baseline,0 mins,5mins,10 mins,15mins,20mins,25mins,30mins,at the end of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the mean number of vasopressor doses required after spinal anaesthesia inthem
To assess the mean fuid requirements following spinal anesthesia in them. |
5mins,10mins,15mins,20mins,25mins,30mins, at the end of surgery
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/09/2025 |
| 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="1"
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
|
Spinal anesthesia, though safe and effective, often leads to hypotension, which can cause serious complications. Conventional preventive strategies like fluid preloading or vasopressors have limited success and potential risks. Therefore, a simple, non-invasive method to predict post-spinal hypotension is needed.
This prospective observational study investigates whether ultrasonographic measurements of the internal jugular vein (IJV), particularly the collapsibility index, can predict the occurrence of hypotension following spinal anesthesia in women undergoing elective total abdominal hysterectomy.
A total of 120 patients (ASA I–II, aged 35–65 years) will be studied. Pre-anaesthetic ultrasonographic IJV parameters (maximum and minimum diameter, area, and collapsibility index) will be recorded and correlated with intraoperative blood pressure changes. The primary outcome is the incidence of post-spinal hypotension; secondary outcomes include fluid requirements and vasopressor use.
Statistical analysis will assess sensitivity, specificity, and predictive values of IJV ultrasonography. If validated, this technique could help anesthesiologists identify high-risk patients and initiate timely preventive measures, improving patient safety |