| CTRI Number |
CTRI/2024/08/072647 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Haemodynamic responses with or without leg raising after spinal anaesthesia in lower abdominal surgeries |
|
Scientific Title of Study
|
A prospective interventional randomized controlled study to determine the difference in Haemodynamic Parameters with or without leg elevation after spinal anaesthesia in lower abdominal surgeries in Department of Anaesthesiology, SMS Medical college and attached Hospitals, Jaipur |
| 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 Siddhartha Sharma |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical college and attached Hospitals, Jaipur |
| Address |
Department of Anaesthesiology, SMS Medical college and attached Hospitals, JLN Marg Jaipur, Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829950020 |
| Fax |
|
| Email |
drsiddharthasharma@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhartha Sharma |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical college and attached Hospitals, Jaipur |
| Address |
Department of Anaesthesiology, SMS Medical college and attached Hospitals, JLN Marg Jaipur, Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829950020 |
| Fax |
|
| Email |
drsiddharthasharma@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Sharma |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical college and attached Hospitals, Jaipur |
| Address |
Department of Anaesthesiology, SMS Medical college and attached Hospitals, JLN Marg Jaipur, Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9602993826 |
| Fax |
|
| Email |
ashok.asksharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical college and attached Hospitals,JLN Marg, Adarsh nagar,JAIPUR,RAJASTHAN, India, Pin Code:302004 |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical college and attached Hospitals Jaipur |
| Address |
S.M.S. college JLN Marg, Adarsh nagar , JAIPUR, RAJASTHAN, India, Pin Code:- 302004 |
| 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 Ashok Sharma |
SMS Medical college and attached Hospitals, Jaipur |
General surgery Operation theatre, department of Anaesthesiology
Jaipur
RAJASTHAN |
9602993826
ashok.asksharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics committee, SMS Medical college and attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Leg raising After Spinal anesthesia |
Patients in whom the legs will be raised by 30 degree by keeping a pillow below ankles after administrating spinal anaesthesia |
| Comparator Agent |
Without leg raising After Spinal anesthesia |
Patients in Whom the legs will be kept horizontal after
administrating Spinal anaesthesia in lower abdominal surgeries. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give written informed consent, Undergoing lower abdominal surgeries under spinal anaesthesia, ASA grade 1&2, Patients aged between 20-60 Years. Height equal or more than 145 cm. |
|
| ExclusionCriteria |
| Details |
Hypotension before spinal anaesthesia
Pregnant patients
Non-coperative and psychiatric patients
Cases where spinal will be converted into general anaesthesia
Patient allergic to study drugs [ Bupivacine , ephedrine ]
Patients with thrombocytopenia or coagulopathy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the effects on hemodynamic parameters { Blood
pressure & Heart rate } with and without leg raising after spinal anesthesia
at different time interval |
1 , 2, 3 , 4 , 5 , 7
, 9, 11 , 13 , 15, 20 minutes and then every 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effects on saturation [Spo2] with and without leg raising
after spinal anesthesia at different time interval |
1 , 2, 3 , 4 , 5 , 7
, 9, 11 , 13 , 15, 20 minutes and then every 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
28/08/2024 |
| 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
|
In this study we will determine the difference in haemodynamic Parameters with or without leg elevation after spinal anaesthesia in lower abdominal surgeries. In this study we will assess and compare the effects on hemodynamic parameters { Blood pressure & Heart rate } with and without leg raising after spinal anaesthesia. |