| CTRI Number |
CTRI/2025/02/080116 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study on the level of block and Hemodynamic Parameters in Unilateral Spinal Anaesthesia Between Two Different Positions in below knee surgery |
|
Scientific Title of Study
|
A Comparative Study On The Level Of Block and Hemodynamic Parameters in Unilateral Spinal Anaesthesia Between Two Different Positions ( Supine vs 10 Degree Reverse Trendelenburg )in below knee surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHWINIV |
| Designation |
Post Graduate MSC Anesthesia technology |
| Affiliation |
SRM Institute of science and technology faculty of medicine and health science |
| Address |
Department of Anesthesiology
B206, B Block, SRM institute of Science and Technology,4th Floor, Kattankulathur campus, Kanchipuram Division, Chengalpattu Dst, Tamilnadu
Department of Anesthesiology
B206, B Block, SRM institute of Science and Technology,4th Floor, Kattankulathur campus, Kanchipuram Division, Chengalpattu Dst, Tamilnadu
Chennai
TAMIL NADU
603203
India |
| Phone |
6369349557 |
| Fax |
|
| Email |
ashwiniviswanathan64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amirdath Prakash R |
| Designation |
Senior Resident |
| Affiliation |
SRM Institute of science and technology faculty of medicine and health science |
| Address |
Department of Anesthesiology
B206, B Block, SRM institute of Science and Technology,4th Floor, Kattankulathur campus, Kanchipuram Division, Chengalpattu Dst, Tamilnadu
Department of Anesthesiology
B206, B Block, SRM institute of Science and Technology,4th Floor, Kattankulathur campus, Kanchipuram Division, Chengalpattu Dst, Tamilnadu
Chennai
TAMIL NADU
603203
India |
| Phone |
9444517870 |
| Fax |
|
| Email |
dramirdath92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwini V |
| Designation |
Post Graduate MSC Anesthesia technology |
| Affiliation |
SRM Institute of science and technology faculty of medicine and health science |
| Address |
Department of Anesthesiology
B206, B Block, SRM institute of Science and Technology,4th Floor, Kattankulathur campus, Kanchipuram Division, Chengalpattu Dst, Tamilnadu
Department of Anesthesiology
B206, B Block, SRM institute of Science and Technology,4th Floor, Kattankulathur campus, Kanchipuram Division, Chengalpattu Dst, Tamilnadu
Chennai
TAMIL NADU
603203
India |
| Phone |
6369349557 |
| Fax |
|
| Email |
ashwiniviswanathan64@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College
Department of Anesthesiology
B206, B Block, SRM institute of Science and Technology,4th Floor, Kattankulathur campus, Kanchipuram Division, Chengalpattu Dst, Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Ashwini v |
| Address |
SRM Institute of Science and Technology,
Department of Anesthesiology
B206, B Block, SRM institute of Science and Technology,4th Floor, Kattankulathur campus, Kanchipuram Division, Chengalpattu Dst, Tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Amirdath Prakash |
SRM Medical College Operation Theatre |
B206, B Block,
Anaesthesia Department
SRM Medical College
Kattankulathur Campus
Kancheepuram
TAMIL NADU |
9444517870
ashwiniviswanathan64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of SRM Medical College Hospital and Research Centre |
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 |
10 Degree reverse trendelenberg position after unilateral spinal anesthesia |
Keeping the patient in a 10 degree reverse trendelenberg position instead of supine to study the level of block and hemodynamic parameters. |
| Intervention |
Supine position after unilateral spinal anesthesia |
Supine position for surgery after giving unilateral spinal anaesthesia and monitoring level of block and hemodynamic parameters. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient admitted for General surgeries / orthopedic surgery procedure, SRM Medical College Hospital &Research Center age of group between 18-65
2.ASA physical Status classification 1 to 3 ,Mallampatti classification 1 to 3
3.Hemodynamically stable patient
4.Surgeries of lower limbs |
|
| ExclusionCriteria |
| Details |
1. Patient refusal /failed Spinal anesthesia
2. History of coagulopathy
3. Infection at the site of injection
4. Severe spinal deformity
5. Allergy to drugs
6. Patient with preexisting neurological deficits
7. Output obstruction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the level of block in Two different position in unilateral Spinal Anesthesia
|
10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the hemodynamic parameter in Two different position in unilateral Spinal Anesthesia
|
Pre spinal, after spinal,5,10, 30 mins , 1 hour, before shifting ,post op |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
18/02/2025 |
| 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="0"
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
|
Traditional spinal anaesthesia accompanies ,profound block duration and hemodynamic changes . The study is to investigate the impact of unilateral spinal anaesthesia different positions in supine and 10 degree reverse trendelenburg position , so as to gain insights on how it may affect the effectiveness of anaesthesia and of hemodynamic changes on patients condition. Hence, we planned to conduct this study |