| CTRI Number |
CTRI/2024/10/075610 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Ultrasound guided measurement of internal jugular vein collapsibility index and carotid intima media thickness to correlate development of spinal hypotension in geriatric patients |
|
Scientific Title of Study
|
Sonographic assessment of internal jugular vein and carotid artery to correlate development of spinal hypotension in geriatric 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 |
AMI PATEL |
| Designation |
Post Graduation Resident |
| Affiliation |
Dr D Y Patil Medical College And Hospital Kadamwadi Kolhapur Maharashtra |
| Address |
Department of Anaesthesiology Dr D Y Patil Medical College And Hospital Kadamwadi Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
8849129610 |
| Fax |
|
| Email |
dramipatel99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archita Patil |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil Medical College And Hospital Kadamwadi Kolhapur Maharashtra |
| Address |
Department of Anaesthesilogy Dr D Y Patil Medical College And Hospital Kadamwadi Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9326853458 |
| Fax |
|
| Email |
drarchita@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
AMI PATEL |
| Designation |
Post Graduation Resident |
| Affiliation |
Dr D Y Patil Medical College And Hospital Kadamwadi Kolhapur Maharashtra |
| Address |
Department of Anaesthesiology Dr D Y Patil Medical College And Hospital Kadamwadi Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
8849129610 |
| Fax |
|
| Email |
dramipatel99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y. Patil Medical College And Hospital Research Center,Kadamwadi, Kolhapur, Maharashtra 416003 India |
|
|
Primary Sponsor
|
| Name |
DR D Y Patil Medical College And Hospital Research Center |
| Address |
DR.D.Y. Patil Medical College And Hospital Research Center,Kadamwadi,Kolhapur,Maharashtra 416003 |
| 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 |
| Dr AMI PATEL |
Dr. D. Y. Patil Medical College And Hospital Research Center,Kadamwadi,,Kolhapur |
Department Of Anaesthesiology Kolhapur Maharashtra
Kolhapur
MAHARASHTRA |
8849129610
dramipatel99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,D. Y. Patil Medical College,Kolhapur |
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 |
| Comparator Agent |
Internal jugular vein collapsibility index and carotid intima media thickness |
To detect post spinal hypotension |
| Intervention |
Sonographic assessment of carotid artery |
To evaluate carotid intima- media thickness to detect hypotension after spinal anaesthesia in geriatric patients undergoing elective surgery |
| Intervention |
Sonographic assessment of internal jugular vein |
To evaluate Internal jugular vein collapsibility index to detect hypotension after spinal anaesthesia in geriatric patients undergoing elective surgery
|
|
|
Inclusion Criteria
|
| Age From |
66.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group more than 65 years
2)Elective surgery under Spinal Anaesthesia |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)Age group less than 65 years
3)BMI more than 30kg/m2
4)Patients having Central line in situ
5)Patients with disorders like Right Heart Failure, Cor pulmonale, Right-sided valvular heart lesion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To measure the maximum and minimum IJV diameter
2)To correlate Internal Jugular Vein Collapsibility Index (IJV-CI) with Spinal Hypotension
|
Using Standard anaesthetic protocol patient will be given spinal anaesthesia. Pulse and systolic, diastolic and mean blood pressure values will be measured at 5 Minute intervals for the first 20 minutes, and then every 10 minutes up to 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To measure carotid intima-media thickness (CIMT)
2)To correlate CIMT with Spinal Hypotension
|
Sonographic assessment of carotid artery intima media thickness to correlate development of post spinal anaesthesia hypotension upto 1 hour after giving spinal anesthesia |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
29/10/2024 |
| 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 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
|
Hypotension after spinal anesthesia is a common event in routine anesthesia practice Intraoperative hypotension if severe or prolonged is associated with the development of serious conditions such as stroke, acute myocardial infarction, heart and kidney failure, prolonged hospitalization and increased risk of postoperative mortality Noninvasive and simple methods such as sonographic evaluation of the internal jugular vein (IJV) and carotid intima media thickness This study aimed to investigate whether the sonographic measurements of IJV and carotid artery are an effective and useful diagnostic tool to detect post-spinal hypotension in elderly patients undergoing elective surgery
|