| CTRI Number |
CTRI/2024/09/073612 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting fall In blood pressure after general anaesthesia in adult patients undergoing elective surgery by using ultrasonography of neck and thigh vessels |
|
Scientific Title of Study
|
Evaluating and comparing corrected flow time and respiratory variation of peak blood flow velocity and waveform in carotid and femoral artery for prediction of hypotension after induction of general anaesthesia in adult patients undergoing elective surgery - A cross sectional 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 |
Abhishek Thakur |
| Designation |
Post Graduate Student |
| Affiliation |
Dr RPGMC Kangra at Tanda Himachal Pradesh |
| Address |
Room Number 101 Operation Theatre Complex 3rd floor Department of Anaesthesiology Dr RPGMC Kangra at Tanda Himachal Pradesh
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
09459366204 |
| Fax |
|
| Email |
rabhitsaklani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhanu Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Dr RPGMC Kangra at Tanda |
| Address |
Department of Anaesthesiology Dr RPGMC Kangra at Tanda Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418016807 |
| Fax |
|
| Email |
bhanurpgmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Thakur |
| Designation |
Post Graduate Student |
| Affiliation |
Dr RPGMC Kangra at Tanda |
| Address |
Room Number 101 Operation Theatre Complex 3rd floor Department of Anaesthesiology
Dr RPGMC Kangra at Tanda Himachal Pradesh
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
9459366204 |
| Fax |
|
| Email |
rabhitsaklani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Superintendent Office Room Number 203 First Floor Block A Dr RPGMC Kangra at Tanda District Kangra State Himachal Pradesh, India ,Pin code 176002 |
|
|
Primary Sponsor
|
| Name |
Abhishek Thakur |
| Address |
Department of Anaesthesiology Dr RPGMC Kangra at Tanda district Kangra state Himachal Pradesh India 176002
Himachal Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Abhishek Thakur |
Dr RPGMC Kangra Hospital at Tanda Himachal Pradesh |
Operation Theatre Complex 3rd floor Department of Anaesthesiology Dr RPGMC Kangra at Tanda Himachal Pradesh 176001
Kangra
HIMACHAL PRADESH |
9459366204
rabhitsaklani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Dr RPGMC Kangra at Tanda |
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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA class 1 and 2 physical status , BMI 18.5-29.9 , patients undergoing elective surgeries requiring general anaesthesia, patients willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
Patients refusing for participation in study. Haemodynamically unstable patients. Patients with ASA class 3 and more physical status. Pt having co-existing diseases like hypertension, diabetes mellitus, renal disease, cerebrovascular disease, peripheral arterial disease, atherosclerosis, any cardiac rhythm other than sinus, cardiomyopathy and history of neck surgery in past. Patients with BMI more than 30. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating and comparing corrected flow time and respiratory variation of peak blood flow velocity and waveform in carotid and femoral artery for prediction of hypotension after induction of general anaesthesia |
1 min 2 min 3 min 4 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Calculate dose of propofol ( in mg) required for induction of anaesthesia |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/10/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included rabhitsaklani@gmail.com).
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Induction of general anaesthesia is associated with hemodynamic changes including hypotension in patients undergoing surgery. With development of newer techniques like point of care ultrasound these impending hemodynamic changes can be predicted. Corrected flow time and respiratory variations of peak blood flow velocity and waveform in carotid and femoral arteries can be used for prediction of hypotension. Carotid and femoral arteries are superficial arteries and can be easily assessed using ultrasonography and thus can help in prediction of hypotension during induction of anaesthesia. |