| CTRI Number |
CTRI/2024/11/077209 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Following induction of general anaesthesia there will be fall in blood pressure which can be predicted by measuring the diameter of veins like internal jugular vein ,axillary vein in the pre operative period so sudden fluctuations of blood pressure in intra operative period can be avoided. |
|
Scientific Title of Study
|
Prediction of hypotension following induction of general anaesthesia by pre-anaesthesia ultrasonographic measurements of diameter variations of internal jugular vein versus axillary vein to modified passive leg raising: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 |
HEMALAKSHMI S P |
| Designation |
Postgraduate medical student |
| Affiliation |
Bangalore Medical College And Research Institute |
| Address |
Department of anaesthesiology,
Bangalore medical college and research institute,KR market,
Bangalore,Karnataka.
Bangalore
KARNATAKA
560002
India |
| Phone |
8220250240 |
| Fax |
|
| Email |
thegirllakshh1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Nethra.S.S |
| Designation |
Professor and head of the department |
| Affiliation |
Bangalore Medical College And Research Institute |
| Address |
Department of anaesthesiology,
Bangalore medical college and research institute,KR market,
Bangalore,Karnataka.
Bangalore
KARNATAKA
560002
India |
| Phone |
9448171403 |
| Fax |
|
| Email |
nethra.surhonne@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSwathiN |
| Designation |
Assistant professor |
| Affiliation |
Bangalore Medical College And Research Institute |
| Address |
Department of anaesthesiology,
Bangalore medical college and research institute,KR market,
Bangalore,Karnataka.
Bangalore
KARNATAKA
560002
India |
| Phone |
9972454989 |
| Fax |
|
| Email |
swathisaggi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College And Research Institute,KR market,Bangalore-560002,Karnataka |
|
|
Primary Sponsor
|
| Name |
HEMALAKSHMI S P |
| Address |
Department of anaesthesiology,
Bangalore medical college and research institute,KR market,
Bangalore,Karnataka. |
| Type of Sponsor |
Other [person doing the study,postgraduate student.] |
|
|
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 |
| DrSwathiN |
Bangalore Medical College And Research Institute |
Department Of Anaesthesiology,Major operation theatre,Bangalore Medical College And Research Institute,KR market,Bangalore,KARNATAKA
Bangalore
KARNATAKA |
09972454989
swathisaggi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R031||Nonspecific low blood-pressure reading, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age between 18-50 years
2.Patients willing to give informed written consent(Annexure 1)
3.Patients belonging to American Society of Anesthesiologist class 1&2 (Annexure 2)
4.Patients scheduled to undergo elective surgeries under general anaesthesia.
5.Sex-males and females. |
|
| ExclusionCriteria |
| Details |
1.Patients who are hemodynamically unstable
2.Patients with cardiac, renal, liver or respiratory diseases.
3.Patients undergoing emergency surgeries.
4.Pregnant women.
5.Patients with peripheral vascular disease or proven vascular syndromes like thoracic outlet syndrome or subclavian steal syndrome.
6.Patients with Subclavian or Internal jugular vein cannulae in situ or were cannulated atleast 2 months prior.
7.Psychiatric patients.
8.Patients with unclear ultra sound images.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ï‚·Measurement of Heart rate Systolic blood pressure Diastolic blood pressure Mean arterial pressure at serial intervals in intra operative period
|
Systolic blood pressure Diastolic blood pressure Mean arterial pressure measurements at every 1 min interval for about 15 mins from the induction of anaesthesia till the beginning of first incision |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ï‚·Occurrence of hypotension & the requirement of fluid bolus & vasopressor will be noted |
every 1 min interval for about 15 mins from the induction of anaesthesia till the beginning of first incision |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
05/12/2024 |
| 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 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
|
Hypotension in the peri operative period essentially implies organ hypoperfusion and hence must be evaluated and prevented. One third of all hypotensive episodes in major surgeries occur between the induction of anaesthesia and incision. General anaesthetic drugs due to vasodilatation or circulatory depression lead to hypotension, which could be more profound if there is hypovolemia as well. By predicting the occurrence of hypotension,hypovolemia can be corrected and catastrophic consequences can be avoided in high risk patients Hence, our aim is to predict hypotension following induction of anaesthesia by measuring internal jugular versus axillary vein diameter variation following passive leg raising test. |