| CTRI Number |
CTRI/2021/04/033294 [Registered on: 30/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of changes in Internal jugular vein and inferior vena cava diameters and post induction hypotension |
|
Scientific Title of Study
|
Preanaesthetic ultrasonographic evaluation of changes in Internal jugular vein and inferior vena cava parameters and its association with post induction hypotension: A Prospective Exploratory 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 SANJAY AGRAWAL |
| Designation |
PROFESSOR AND HEAD, ANAESTHESIOLOGY |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, LEVEL-6, MEDICAL COLLEGE WING, AIIMS RISHIKESH, VIRBHADRA ROAD, RISHIKESH, DEHRADUN,UTTARANCHAL, INDIA
249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9761712630 |
| Fax |
|
| Email |
sanjay.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
VAISHALI GUPTA |
| Designation |
JUNIOR RESIDENT, ACADEMICS |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, LEVEL-6, MEDICAL COLLEGE WING, AIIMS RISHIKESH, VIRBHADRA ROAD, RISHIKESH, DEHRADUN,UTTARANCHAL, INDIA
249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9463218070 |
| Fax |
|
| Email |
vaishaligupta0671@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJAY AGRAWAL |
| Designation |
PROFESSOR AND HEAD, ANAESTHESIOLOGY |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, LEVEL-6, MEDICAL COLLEGE WING, AIIMS RISHIKESH, VIRBHADRA ROAD, RISHIKESH, DEHRADUN,UTTARANCHAL, INDIA
249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9761712630 |
| Fax |
|
| Email |
sanjay.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE, VIRBHADRA ROAD, RISHIKESH, DEHRADUN, UTTARANCHAL |
| Type of Sponsor |
Research institution and 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 |
| VAISHALI GUPTA |
AIIMS RISHIKESH |
MAJOR OT COMPLEX, LEVEL-6, BLOCK-B
Dehradun
UTTARANCHAL |
9463218070
vaishaligupta0671@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS RISHIKESH |
Approved |
|
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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 |
Evaluation of change in internal jugular vein and inferior vena cava diameter and collapsibility index in supine and 10 degree trendelenburg position and its association with post induction hypotension |
Evaluation of change in internal jugular vein and inferior vena cava diameter and collapsibility index in supine and 10 degree trendelenburg position and its association with post induction hypotension |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients under ASA I and II
Undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Refusal to participate
Major peripheral vascular disease, unstable angina or ejection fraction<40%, implanted pacemaker/cardioverter, history of heart failure, autonomic nervous system disorders
Respiratory distress, increased intraabdominal pressure, difficult airway
Mental incompetence
Patients currently taking angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta blockers and calcium channel blockers |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate changes in internal jugular vein diameter and collapsibilty index in supine and 10 degree trendelenberg position and its association with post induction hypotension
To evaluate changes in inferior vena cava diameter and collapsibilty index in supine and 10 degree trendelenberg position and its association with post induction hypotension |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate correlation between changes in diameters of internal jugular vein and inferior vena cava in supine and 10 degree trendelenburg position with post induction hypotension
To evaluate correlation between internal jugular vein and inferior vena cava collapsibilty index with post induction hypotension |
1year 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2021 |
| Date of Study Completion (India) |
20/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, after screening of eligible candidates and after taking written informed consent, preoperative ultrasonographic assessment of diameter and collapsibility index of internal jugular vein and inferior vena cava will be done first in supine followed by 10 degree trendelenberg position. After standard induction, post induction blood pressure measurements will be taken and association between changes in internal jugular vein and inferior vena cava parameters and post induction hypotension will be done. Aim of the study is to evaluate the changes in internal jugular vein and inferior vena cava parameters and its association with post induction hypotension. |