| CTRI Number |
CTRI/2024/05/067128 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasonographic assessment of neck and forearm vessel so as to predict fall in blood pressure in old age patients after giving anaesthesia. |
|
Scientific Title of Study
|
Corrected flow time and respiratory variations of peak systolic blood flow velocity of carotid artery and radial artery as predictors of general anaesthesia induced hypotension in elderly 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 |
Dr Vimaljeet Singh |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology Maulana Azad Medical College Campus,2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India |
| Phone |
9711923506 |
| Fax |
|
| Email |
vimaljeet_s@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kohli |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology Maulana Azad Medical College Campus,2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India |
| Phone |
9818073402 |
| Fax |
|
| Email |
dramitkohli@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimaljeet Singh |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology Maulana Azad Medical College Campus,2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India |
| Phone |
9711923506 |
| Fax |
|
| Email |
vimaljeet_s@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Elderly patients (60 years and above) posted for elective surgery under general anaesthesia at Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Maulana Azad Medical College Campus,2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002 |
| 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 Vimaljeet Singh |
Lok Nayak Hospital |
OT block, Lok Nayak Hospital and associated G.I.P.M.E.R., Guru Nanak Eye Eye Centre, Delhi Gate, Central Delhi
Central
DELHI |
09711923506
vimaljeet_s@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I952||Hypotension due to drugs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists physical status class of 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with a body mass index (BMI) less than18 kg/m2 or more than 30 kg/m2.
Patients with cardiomyopathy, moderate to severe valve disease, pulmonary hypertension.
Patients with previous neck surgery/trauma or neck contractures.
Patients with peripheral vascular diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensitivity and specificity of FTc of carotid artery for post induction hypotension in elderly patients.
Sensitivity and specificity of FTc of radial artery for post induction hypotension in elderly patients. |
After induction every 1 minute for 10 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of ΔVpeak of carotid artery for post induction hypotension in elderly patients. |
After induction every 1 minute for 10 minutes. |
| Sensitivity and specificity of ΔVpeak of radial artery for post induction hypotension in elderly patients. |
After induction every 1 minute for 10 minutes. |
| Correlation of preanaesthetic FTc , ΔVpeak of carotid and radial artery with percentage decrease in SBP, MAP and HR. |
After induction every 1 minute for 10 minutes. |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
20/05/2024 |
| 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="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
|
We are evaluating preoperative corrected flow time and respiratory variations of peak systolic blood flow velocity of carotid artery and radial artery as predictors of general anaesthesia induced hypotension in elderly patients. The aim of of our study is to evaluate the role of ultrasound guided carotid artery and radial artery corrected flow time (FTc) and respiratory variations of peak blood flow velocity (ΔVpeak) as predictors of post induction hypotension. |