| CTRI Number |
CTRI/2024/04/065013 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical study |
| Study Design |
Other |
|
Public Title of Study
|
To find out whether can we efficiently predict occurrence of post spinal hypotension by ultrasonographic evaluation of internal jugular vein in supine and trendelenburg position (15 degree head down position) |
|
Scientific Title of Study
|
Preoperative ultrasonographic evaluation of rate of change of internal jugular vein cross sectional area from supine to trendelenburg position for the prediction of post spinal hypotension in orthopaedic surgeries: 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 |
Dr Satveer Singh Gurjar |
| Designation |
Associate professor |
| Affiliation |
Sawai man Singh medical College jaipur |
| Address |
Department of Anaesthesia 2 nd floor dhanvantri building Sawai man Singh medical College jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8890160492 |
| Fax |
|
| Email |
archveer.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satveer Singh Gurjar |
| Designation |
Associate professor |
| Affiliation |
Sawai man Singh medical College jaipur |
| Address |
Department of Anaesthesia 2 nd floor dhanvantri building Sawai man Singh medical College jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8890160492 |
| Fax |
|
| Email |
archveer.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidyashree DN |
| Designation |
Junior resident |
| Affiliation |
Sawai Man Singh medical College jaipur |
| Address |
Department of Anaesthesia 2 nd floor dhanvantri building Sawai man Singh medical College jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8310438878 |
| Fax |
|
| Email |
sukanavida@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology 2 nd floor Dhanvantari building SMS Medical College Jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai man singh medical College |
| Address |
Department of Anaesthesia 2 nd floor dhanvantri building sms hospital jaipur Rajasthan 302004 |
| 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 Satveer Singh Gurjar |
Sawai Man Singh Medical college and attached hospital |
Department of anaesthesia 2nd floor Dhanvantari building SMS Medical College Jaipur
Jaipur
RAJASTHAN |
8890160492
archveer.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S829||Unspecified fracture of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give informed written consent to participate in study
Adult patients undergoing elective orthopaedic surgeries under spinal anaesthesia aged between 18-55 years
Patients belonging to ASA 1 and 2
BMI of 18-30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients who are medically unfit for spinal anaesthesia and pregnant patients
Patients with baseline arterial SBP less than 90mmhg and MAP less than 70mmhg
Patients with neck deformity or having inability to turn neck will also be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. determining the cut off value of rate of change of IJV cross-sectional area (cm2) with posture
2. determining the sensitivity and specificity of the cut off value of the rate of change of IJV cross-sectional area (cm2) with posture(%)
3.To determine the proportion of complications(hypotension, bradycardia,nausea,vomiting,dysnoea) if any. |
IJV cross sectional area(cm2) in supine and trendelenburg position |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters (HR,SBP,DBP,MAP,Spo2) |
0,1,2,3,4,5 mins,7,9,11,13,15 mins, then every 5 minutes till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
06/05/2024 |
| 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="0"
Months="5"
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 anaesthesia is frequently used routine anaesthesia practice. Spinal induced hypotension is most common effect of spinal anaesthesia and in this study we are evaluating the efficacy of preoperative sonographic measurement of internal jugular vein cross sectional area in supine and trendelenburg position for predicting post spinal hypotension in patients undergoing orthopaedic surgeries. |