| CTRI Number |
CTRI/2021/08/035840 [Registered on: 23/08/2021] Trial Registered Prospectively |
| Last Modified On: |
07/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasonographic measurement of internal jugular vein diameter during normal breathing to help find out whether spinal anaesthesia will cause fall in blood pressure. |
|
Scientific Title of Study
|
Role of ultrasonographic assessment of internal jugular vein distensibility in the prediction of hypotension following spinal anesthesia : an observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kaushal Bhonsle |
| Designation |
Senior Resident |
| Affiliation |
BARC HOSPITAL |
| Address |
2nd floor,Department of Anaesthesiology,BARC Hospital,
Anushaktinagar,Mumbai
Mumbai (Suburban)
MAHARASHTRA
400094
India |
| Phone |
|
| Fax |
|
| Email |
kaushalbhonsle3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKajal Dalal |
| Designation |
Full Time Anaesthesia Consultant |
| Affiliation |
BARC HOSPITAL |
| Address |
2nd floor,Department of Anaesthesiology,BARC Hospital,
Anushaktinagar,Mumbai
Mumbai (Suburban)
MAHARASHTRA
400094
India |
| Phone |
|
| Fax |
|
| Email |
ksdalal@barc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
DrKajal Dalal |
| Designation |
Full Time Anaesthesia Consultant |
| Affiliation |
BARC HOSPITAL |
| Address |
2nd floor,Department of Anaesthesiology,BARC Hospital,
Anushaktinagar,Mumbai
Mumbai (Suburban)
MAHARASHTRA
400094
India |
| Phone |
|
| Fax |
|
| Email |
ksdalal@barc.gov.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesia |
| Address |
Department of Anaesthesiology,
2nd Floor,
B.A.R.C hospital,
Anushaktinagar,
400094
|
| Type of Sponsor |
Other [cental government hospital] |
|
|
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 Kaushal Bhonsle |
main operation theatre |
Department of Anaesthesiology,
2nd Floor,
B.A.R.C hospital,
Anushaktinagar,
400094
Mumbai (Suburban)
MAHARASHTRA |
8007192267
kaushalbhonsle3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| medical ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
usg assessment of IJV |
preloading and its assessment by usg for IJV Distensibility in prediction of hypotension after spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA scores I-II undergoing elective infraumbilical surgeries under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Patients having neck contracture
3. Patient refusal.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasound measurement of right IJV distensibility after preloading and its association with hypotension after spinal anesthesia. |
Usg measurement after preloading and Blood Pressure measurement every 5 minutes for 30 minutes post spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the change in distensibility index before and after preloading. |
before and after preloading |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypotension is an adverse effect seen after spinal anaesthesia and is associated with significant perioperative morbidity,especially in hypovoluemic patients.Ultrasonographic measurement of right ijv distensibility has recently shown to be effective in predicting intravascular volume status and its association in preventing overload and hypotension.The aim of study is to investigate whether right IJV distensibility before and after preloading measured with help of usg can predict the risk of hypotension after spinal anaesthesia |