| CTRI Number |
CTRI/2024/10/075045 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To prevent fall in blood pressure after spinal anaesthesia by wrapping of both lower legs in Pregnant patient delivering baby by operation |
|
Scientific Title of Study
|
Evaluation of Leg Wrapping for the Prevention of Postspinal Hypotension In Cesarean Section under Spinal Anaesthesia-A Prospective,Randomised,control 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 Khemraj Meena |
| Designation |
Senior professor |
| Affiliation |
RNT medical college,udaipur,rajasthan |
| Address |
Department of Anaesthesiology, RNT medical college, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
Khemraj10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khemraj Meena |
| Designation |
Senior professor |
| Affiliation |
RNT medical college,udaipur,rajasthan |
| Address |
Department of Anaesthesiology, RNT medical college, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
Khemraj10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chirag Patidar |
| Designation |
Junior Resident |
| Affiliation |
RNT medical college,udaipur,rajasthan |
| Address |
Department of Anaesthesiology, RNT medical college, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8050246337 |
| Fax |
|
| Email |
patidarchirag18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,RNT Medical College,Udaipur,Rajasthan,India,313001 |
|
|
Primary Sponsor
|
| Name |
Rabindranath Tagore Medical College |
| Address |
Department of Anaesthesiology, RNT Medical College,Udaipur,Rajasthan,India,313001 |
| 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 Chirag Patidar |
MB government hospital |
CLR operation theatre at Pannadhay Rajkiya Mahila Chikitsalaya attached with Rabindra Nath Tagore Medical College, Udaipur, Rajasthan.
Udaipur
RAJASTHAN |
8050246337
patidarchirag18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT medical College and controller and attached hospitals,udaipur |
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 |
| Comparator Agent |
No Use of compression bandaging technique with the help of esmarch bandage in lower limbs to prevent hypotension |
In control group we will not use compression bandaging technique with the help of esmarch bandage in lower limbs to prevent hypotension before giving spinal anaesthesia till the end of c-section |
| Intervention |
Use of compression bandaging technique with the help of esmarch bandage in lower limbs to prevent hypotension |
In intervention group We will use compression bandaging technique with the help of esmarch bandage in both lower limbs starting from ankle to mid-thigh before giving spinal anaesthesia till the end of c-section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Full-term pregnant patients
Uncomplicated pregnancy
Physical status American Society of Anaesthesiologists (ASA) Class I or II
Scheduled for elective lower segment cesarean section under spinal anaesthesia
Hemodynamically stable patient with normal laboratory investigations
Patients willing to be a part of the study |
|
| ExclusionCriteria |
| Details |
Patients with physical status ASA III and more
Hemodynamically unstable patients
Patients with known sensitivity to local anaesthetic
Patients not willing to be a part of the study
Contraindication for spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension |
From induction of patient with spinal anaesthesia to completion of cesarean section |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Haemodynamic changes
2.Requirement of vasopressor (Dose & Timing)
3.Side effects / Complications, if any
|
From induction of patient with spinal anaesthesia to completion of cesarean section |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
18/10/2024 |
| 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 - NO
|
|
Brief Summary
|
My clinical study titled- Evaluation of leg wrapping for the prevention of postspinal hypotension in cesarean section under spinal anaesthesia: A prospective,randomised,control study. Our primary objective will be record of incidence of hypotension and secondary objective will be to know hemodynamic changes,requirement of vasopressor(dose & timing),Side effects/complications,if any.Kindly consider it for CTRI registration. |