| CTRI Number |
CTRI/2024/07/070663 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Effects Of Trendelenburg 20 degree, Passive Leg Raising At 45 Degree And Supine Position On The Hemodynamic Changes After Tourniquet Deflation In Orthopaedic Lower Limb Surgery Under Spinal Anaesthesia |
|
Scientific Title of Study
|
Comparison Of Effects Of Trendelenburg 20 Degree, Passive Leg Raising At 45 Degree And Supine Position On The Hemodynamic Changes After Tourniquet Deflation In Orthopaedic Lower Limb Surgery Under Spinal Anaesthesia - A Prospective Parallel Controlled 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 Upasana Goswami |
| Designation |
Specialist Grade1 |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anesthesia,
Deen Dayal Upadhyay Hospital,
Hari Nagar
West
DELHI
110064
India |
| Phone |
9718990118 |
| Fax |
|
| Email |
upagoswami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upasana Goswami |
| Designation |
Specialist Grade1 |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anesthesia,
Deen Dayal Upadhyay Hospital,
Hari Nagar,
New Delhi
West
DELHI
110064
India |
| Phone |
9718990118 |
| Fax |
|
| Email |
upagoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Upasana Goswami |
| Designation |
Specialist Grade1 |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anesthesia,
Deen Dayal Upadhyay Hospital,
Hari Nagar,
New Delhi
West
DELHI
110064
India |
| Phone |
9718990118 |
| Fax |
|
| Email |
upagoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deen Dayal Upadhyay Hospital,
Hari Nagar,
New Delhi- 110064 |
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay Hospital |
| Address |
Main ortho ot 1 and Emergency ortho trauma ot, Deen Dayal Upadhyay Hospital,
Hari Nagar, New Delhi- 110064 |
| 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 |
| Akshaya A |
Deen Dayal Upadhay Hospital, Hai Nagar, New Delhi |
Main ot 1 , Emergency Trauma Ot,
Deen Dayal Upadhyay Hospital
West
DELHI |
9894581482
akshayaananthan97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee-Deen Dayal Upadhyay Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Passive Leg Raising at 45 degree |
Comparing the effect on hemodynamic parameter among three diffferent groups after torniquet deflation in lower limb orthopedic surgeries under spinal anesthesia |
| Comparator Agent |
Supine position |
Comparing the effect on hemodynamic parameter among three diffferent groups after torniquet deflation in lower limb orthopedic surgeries under spinal anesthesia |
| Comparator Agent |
Trendelenberg at 20 degree
|
Comparing the effect on hemodynamic parameter among three diffferent groups after torniquet deflation in lower limb orthopedic surgeries under spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA(American society of Anaesthesiologist) Physical status grade I/II
2. Age from 18 to 60 years and All sexes
3. Patients undergoing Orthopaedics lower limb surgeries along with use of torniquet under spinal anaesthesia
4. Patients undergoing Orthopaedics lower limb surgeries whose duration of surgery is more than 1 hour
|
|
| ExclusionCriteria |
| Details |
1. Patients with any history of cardiovascular illness
2. Patients requiring bilateral lower limb surgery
3. Any allergy to local anaesthetic drugs
4. Any contraindication for spinal anesthesia
5. Patients undergoing lower limb vascular surgeries
6. Surgeries exceeding allowable tourniquet time
7. Intraoperative hemodynamic instability
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the effect of tredenlenberg 20 degree position,passive leg raise at 45 degree and supine position on mean arterial pressure and heart rate after 5 minutes of torniquet deflation |
to evaluate the effect of tredenlenberg 20 degree position,passive leg raise at 45 degree and supine position on mean arterial pressure and heart rate after 5 minutes of torniquet deflation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
1. Systolic Blood Pressure (SBP) among Trendelenburg 20 degree position, Passive leg raising at 45 degree & supine position after tourniquet deflation.
2. Diastolic Blood Pressure(DBP) among all 3 groups,
3. Need for vasopressors in all 3 groups
4. Amount of intravenous fluid used in all 3 groups
5. Complications in all 3 groups, if any .
|
0,1,2,3,4,5,10,20,30 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/07/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a Prospective Parallel Controlled Study to Compare the effect
of Trendelenburg 20 degree position, Passive leg raising at 45 degree and Supine
position on hemodynamic changes after tourniquet deflation in patients
undergoing Orthopaedic lower limb surgery under Spinal Anaesthesia. Here patients will be allocated into 3 study group by block randomisation with sealed envelope system. We will prepare
fifteen randomly generated treatment allocations within sealed opaque envelopes
assigning T, P and C in 5 envelopes each, where T represents Trendelenburg 20degree
group, P represents PLR 45 degree group and C represents control group with supine
position. Once a patient will consent to enter a trial, an envelope will be
opened and the patient will then be offered the allocated group. In this
technique, patients will be randomised in a series of blocks of fifteen.After whic hemodynamic parameters will be monitored and recorded at baseline,0,1,2,3,4,5,10,20,30 minutes and need of vasopressors and IV fluid usuage, Torniquet inflation and Deflation time will be recorded. |