| CTRI Number |
CTRI/2023/12/060608 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
06/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of shivering in drugs of Mirtazapine , Dexamethasone and Tramadol after spinal anaesthesia |
|
Scientific Title of Study
|
A comparative study on the effects of Mirtazapine ,Dexamethasone and Tramadol for prevention of post spinal shivering in Gynaecological Surgeries in a tertiary care hospital chengalpattu district -a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SRINIVASAN T |
| Designation |
Post Graduate |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur- Guduvanchery main road , Ammapettai , Nellikuppam , Kancheepuram , Tamil Nadu .
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9940831438 |
| Fax |
|
| Email |
srisachinx0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DILIP LUMAR G |
| Designation |
Professor |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur- Guduvanchery main road , Ammapettai , Nellikuppam , Kancheepuram , Tamil Nadu .
PIN-603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9094940243 |
| Fax |
|
| Email |
dilipko@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DILIP KUMAR G |
| Designation |
Professor |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur- Guduvanchery main road , Ammapettai , Nellikuppam , Kancheepuram , Tamil Nadu .
PIN-603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9094940243 |
| Fax |
|
| Email |
dilipko@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , Shri sathya sai medical college and research institute , Thiruporur -Guduvancherry main road ,Ammapettai ,Nellikuppam , Kancheepuram ,Tamil Nadu ,603108 ,INDIA |
|
|
Primary Sponsor
|
| Name |
SRINIVASAN T |
| Address |
1/223 chinnapulliyur , Elavamalai post , Vasavi college via , Bhavani TK , Erode DT , Tamil Nadu pin-638316 |
| 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 |
| SRINIVASAN T |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
First Floor OT Complex, Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute , Thiruporur-Guduvancherry main road , Nellikuppam , Ammapettai , Kancheepuram , Tamil Nadu , India , Pin-603018
Kancheepuram
TAMIL NADU |
9940831438
srisachinx0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone and Tramadol |
Intravenous Dexamethasone 8mg in 100ml NS over 15 minutes
Intravenous Tramadol 1mg per Kg in 100ml NS over 15 minutes |
| Intervention |
Mirtazapine |
Mirtazapine 30mg per oral stat |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients giving valid consent
Patients under ASA physcial status I and II
Patients underwent gynecological surgeries under spinal anesthesia
Patients of female gender aged between 20 to 45 years |
|
| ExclusionCriteria |
| Details |
Patients who are not giving valid consent
Patient under ASA physical status III or more
Patients with thyroid disease , obesity , fever and compromised cardiovascular status , Pyschological , seizure , coagulopathy disorder , Diabetic patients and peptic ulcer disease patients and those who are allergic to any of these drugs
Body mass Index more than 35 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the occurrence and severity of shivering following spinal anesthesia |
Severity of shivering in postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of mirtazapine , Dexamethasone and Tramadol in post spinal anesthesia shivering |
Postoperative period |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 3 |
|
Date of First Enrollment (India)
|
27/12/2023 |
| 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
|
A comparative study on the effects of Mirtazapine ,Dexamethasone and Tramadol for prevention of post spinal Anaesthesia shivering in Gynaecological Surgeries in a Tertiary care Hospital ,Chengalpattu District -A Randomized controlled trial
Primary objective : To evaluate the occurence and severity of shivering following spinal anaesthesia
Secondary objective : To compare the effectiveness of Mirtazapine , Dexamethasone and Tramadol in post spinal anaesthesia shivering and other adverse effects , hemodynamic changes. |