| CTRI Number |
CTRI/2025/06/089602 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Randomised Controlled Trial ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO ANALYSE THE EFFECT OF TOURNIQUET RELEASE IN DIFFERENT LIMB POSITIONS ON HEMODYNAMICS IN LOWER LIMB ORTHOPAEDIC SURGERIES |
|
Scientific Title of Study
|
TO ANALYSE THE EFFECT OF TOURNIQUET RELEASE IN DIFFERENT LIMB POSITIONS ( i.e neutral and elevated to 30 degree from neutral position ) ON HEMODYNAMIC PARAMETERS ( i.e HR , BP , SpO2 , Core temperature , End tidal CO2 and respiratory rate ) IN LOWER LIMB ORTHOPAEDIC SURGERIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MMMCH/IEC/24/874 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajas Rawal |
| Designation |
Junior Resident |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Department of Anaesthesia , Maharishi Markandeshwar Medical College and Hospital , Kumarhatti-Solan , Himachal Pradesh
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8054936963 |
| Fax |
|
| Email |
rajas.rawal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balvir Singh Sekhon |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Department of Anaesthesia , Maharishi Markandeshwar Medical College and Hospital , Kumarhatti-Solan , Himachal Pradesh
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9814030551 |
| Fax |
|
| Email |
drbsekhon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajas Rawal |
| Designation |
Junior Resident |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Department of Anaesthesia , Maharishi Markandeshwar Medical College and Hospital , Kumarhatti-Solan , Himachal Pradesh
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8054936963 |
| Fax |
|
| Email |
rajas.rawal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia , Maharishi Markandeshwar Medical College and Hospital , Kumarhatti-Solan , Himachal Pradesh , India 173229 |
|
|
Primary Sponsor
|
| Name |
Dr Rajas Rawal |
| Address |
Department of Anaesthesia , Maharishi Markandeshwar Medical College and Hospital , Kumarhatti - Solan , Himachal Pradesh , India - 173229 |
| 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 Rajas Rawal |
Maharishi Markandeshwar Medical Colllege and Hospital , Kumarhatti-Solan , Himachal Pradesh |
OT Complex , Third Floor , Maharishi Markandeshwar Medical College and Hospital
Solan
HIMACHAL PRADESH |
8054936963
rajas.rawal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Medical College and Hospital Ethics Committee |
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 |
TO ANALYSE THE EFFECT OF TOURNIQUET RELEASE IN DIFFERENT LIMB POSITIONS ON HEMODYNAMICS IN LOWER LIMB ORTHOPAEDIC SURGERIES |
TO ANALYSE HEMODYNAMIC CHANGES AFTER TOURNIQUET RELEASE IN NEUTRAL POSITION AND INCLINATION IN 30 DEGRESS FROM NEUTRAL POSITION IN LOWER LIMB ORTHOPAEDIC SURGERIES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects undergoing lower limb orthopaedic surgeries
Subjects Grade I and II of ASA
Subjects with tourniquet inflation duration greater than 1 hour |
|
| ExclusionCriteria |
| Details |
Subjects not willing to consent
Subjects Grade III and IV of ASA
Subjects with tourniquet inflation duration greater than 2 hours
Subjects undergoing bilateral lower limb orthopaedic procedure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure and compare the changes in hemodynamic parameters i.e heart rate , blood pressure , oxygen saturation and core temperature in neutral and upwards inclination of 30 degrees limb position after tourniquet is released .
|
Hemodynamic parameters monitoring will be done at intervals of 1 minute , 3 minute , 5 minute and 10 minute . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure and compare changes in respiratory rate and EtCO2 levels in neutral and 30 degrees limb elevation after tourniquet is released |
The parameters monitoring will be done at intervals of 1 minute , 3 minute , 5 minute and 10 minute . |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/07/2025 |
| 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="6"
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
|
Monitoring of hemodynamics will be done throughout the orthopaedic procedure including after inflation of tourniquet . The purpose of the study is to measure and compare changes in hemodynamic parameters i.e heart rate , blood pressure , oxygen saturation and core temperature in neutral and upwards inclination of 30 degrees limb position after tourniquet is released and to measure and compare changes in respiratory rate and EtCO2 levels in neutral and 30 degrees limb elevation after tourniquet is released . The study enrolling of 100 subjects will be randomly allocated into two groups , Group A ( 50 subjects ) whose hemodynamic parameters monitoring shall be done after tourniquet deflation in neutral position and Group B ( 50 subjects ) whose hemodynamic parameters monitoring shall be done after tourniquet deflation in elevation of 30 degrees from neutral position .
|