| CTRI Number |
CTRI/2024/05/068065 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of internal jugular vein collapsibility index in anticipating occurrence of low blood pressure after spinal anaesthesia in old patients. |
|
Scientific Title of Study
|
Pre-anaesthetic ultrasonographic assessment of internal jugular vein collapsibility index as predictor of postspinal induced hypotension in elderly patients. |
| 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 Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
Pt. B. D. Sharma PGIMS,
Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
Pt. B. D. Sharma PGIMS,
Rohtak.
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shewta |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology,
Pt. B. D. Sharma PGIMS,
Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9996630317 |
| Fax |
|
| Email |
shweta95tanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology, Pt. B. D. Sharma PGIMS, Rohtak - 124001, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS |
| Address |
Dept. of Anaesthesiology, Pt. B. D. Sharma PGIMS, Rohtak 124001 Haryana, India |
| 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 |
| Dr Jatin Lal |
Pt. B. D. Sharma PGIMS. |
Dept. of Anaesthesiology, Pt. B. D. Sharma PGIMS, Rohtak - 124001, Haryana, India
Rohtak
HARYANA |
9728265511
dr.jatinlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt. B. D. Sharma PGIMS/UHS, Rohtak |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
- Elderly patients (age≥60 years) scheduled to undergo infraumbilical surgeries under spinal anaesthesia in supine position.
- Patients with ASA physical status classification I and II. |
|
| ExclusionCriteria |
| Details |
1. Patients having uncontrolled hypertension.
2. Patient undergoing unilateral spinal anaesthesia.
3. Severe cardiovascular disease.
4. Autonomic nervous system disorder.
5. Patients with BMI more than 30 kg/square meter.
6. Uncooperative patients.
7. Patient refusal to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess correlation between internal jugular vein collapsibility index and hypotension after spinal anaesthesia. |
Systolic blood pressure, Diastolic blood pressure, Mean blood pressure measurements at baseline (before giving spinal anaesthesia), 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min and 30 min after giving spinal anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension after spinal anaesthesia. |
Systolic blood pressure, Diastolic blood pressure, Mean blood pressure measurements at baseline (before giving spinal anaesthesia), 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min after giving spinal anaesthesia. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/06/2024 |
| Date of Study Completion (India) |
03/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 present prospective, nonrandomised double blind observational study will be conducted in the Department of Anaesthesiology and Critical care, Pt B. D. Sharma, PGIMS, Rohtak, in 90 adult patients (ASA I and II) of either sex aged > 60 years, posted for infraumbilical surgeries under spinal anaesthesia in supine position. The aim of present study is to evaluate utility of internal jugular vein (IJV) collapsibility index in predicting post spinal hypotension in patients undergoing infraumbilical surgeries under spinal anaesthesia. The primary objective of the study is to assess correlation between IJV collapsibility index and hypotension after spinal anaesthesia. The secondary objective is to assess incidence of hypotension after spinal anaesthesia. |