| CTRI Number |
CTRI/2024/12/078410 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of the drugs Pethidine and Dexmedetomidine in controlling shivering during and after surgery done under spinal anesthesia. |
|
Scientific Title of Study
|
Control of intraoperative and postoperative Shivering - A comparative study between Pethidine and Dexmedetomidine under Spinal Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANIKANDAN C |
| Designation |
Junior resident |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
Room no.115,MENS PG HOSTEL
SRI DEVARAJ URS MEDICAL COLLEGE
TAMAKA
KOLAR
15/266, KULLA PERUMAL STREET,
PALACODE, DHARMAPURI DISTRICT,
TAMILNADU. 636808
Kolar
KARNATAKA
563101
India |
| Phone |
08277490807 |
| Fax |
|
| Email |
mk.manikandan04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran N |
| Designation |
Professor |
| Affiliation |
Sri Devaraj URS medical college |
| Address |
Dr Kiran N
Department of Anaesthesiology
Sri Devaraj URS medical college
Tamaka
Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9740468460 |
| Fax |
|
| Email |
Dr.nkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran N |
| Designation |
Professor |
| Affiliation |
Sri Devaraj URS medical college |
| Address |
Department of Anaesthesiology
Sri Devaraj URS medical college
Tamaka
Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9740468460 |
| Fax |
|
| Email |
Dr.nkiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj URS Medical College |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj URS Medical College |
| Address |
TAMAKA
KOLAR
KARNATAKA, 563101 |
| 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 MANIKANDAN C |
Sri Devaraj URS Medical College |
Department of Anaesthesiology
Tamaka
Kolar
Karnataka
Kolar
KARNATAKA |
8277490807
mk.manikandan04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intravenous injection Dexmedetomidine |
administration of intravenous drug of dose 0.5mcg/kg over 5 mins once |
| Intervention |
Intravenous injection Pethidine |
intravenous injection of dose 0.5mg/kg over 5 minutes once |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female included
2.ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.History of cardiac, renal, or hepatic disease.
2.Patients who are known allergic to study drugs.
3.Contraindication to spinal anaesthesia
4.Any need for blood transfusion during intraoperative period
5.Major procedures where heat loss due to surgical exposure
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know about the time required for cessation of shivering after the administration of study drug in patients undergoing spinal anaesthesia |
at the point when shivering stops |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
02/01/2025 |
| 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="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
|
Shivering is the most common complication of spinal anaesthesia. Our aim is to control shivering with usage of drugs and to know about the time taken to control intraoperative and postoperative shivering after the administration of test drug. And the objective is to study about the time required for cessation of shivering after the administration of study drug in patients undergoing spinal anaesthesia. With this, we can know which drug is effective in controlling shivering intra and postoperatively.
|