| CTRI Number |
CTRI/2019/03/018263 [Registered on: 26/03/2019] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING TWO DRUGS DEXMEDETOMIDINE AND TRAMADOL IN TREATING SHIVERING PRESENTING AFTER GIVING SPINAL ANESTHESIA |
|
Scientific Title of Study
|
Randomized Double Blind Study Of Dexmedetomidine Hydrochloride And Tramadol Hydrochloride For Treatment Of Post-Spinal Anesthesia Shivering |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinitya Kollu |
| Designation |
1st Year Post Graduate Student Of Anesthesia |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department Of Anesthesiology, Kalinga Institute Of Medical Sciences, Bhubaneshwar, Orissa
Khordha
ORISSA
751024
India |
| Phone |
9078489407 |
| Fax |
|
| Email |
nityak9228@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LINGARAJ SAHU |
| Designation |
Associate Prof, |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPT. OF ANAESTHESIOLOGY, KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR, ORISSA
Khordha
ORISSA
751024
India |
| Phone |
8280166501 |
| Fax |
|
| Email |
drlingarajsahu.2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srinitya Kollu |
| Designation |
1st Year Post Graduate Student Of Anesthesia |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department Of Anesthesiology, Kalinga Institute Of Medical Sciences, Bhubaneshwar, Orissa
Khordha
ORISSA
751024
India |
| Phone |
9078489407 |
| Fax |
|
| Email |
nityak9228@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Srinitya Kollu , 2D 46,KIMS Girls Hostel,Campus 5,Patia,Bhubaneshwar |
|
|
Primary Sponsor
|
| Name |
Dr Srinitya Kollu |
| Address |
2D 46,KIMS Girls Hostel,Campus 5,Patia,Bhubaneshwar |
| 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 |
| Dr Srinitya Kollu |
Department Of Anesthesiology, Pradhyumna Bal Hospital , KIMS, Patia |
Department Of Anesthesiology, Pradhyumna Bal Hospital ,KIMS ,Patia ,Bhubaneshwar-24
Khordha
ORISSA |
9078489407
nityak9228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SHIVERING POST SPINAL ANAESTHESIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine Hydrochloride |
It is an selective alpha-2 agonist.
Dose-0.5mcg/kg over a period of 5mins infusion at the rate of 1.5ml/kg/hr. |
| Comparator Agent |
Tramadol Hydrochloride |
It is a commonly used opiod drug.It acts on kappa receptors.Dose-0.5mg/kg over a period of 5mins infusion at the rate of 1.5ml/kg/hr. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: Above 18yrs of age.
2.American Society of Anaesthesiologists physical status I ,II, and III.
3.Developed shivering after spinal anaesthesia .
4.Patients who have given consent voluntarily |
|
| ExclusionCriteria |
| Details |
1.American society of anesthesiologists physical status IV and V.
2.Patient with hepatic or renal disease, thyroid disorders,psychiatric disorders.
3.Patients with history of alcohol or substance abuse.
4.Hemodynamically unstable patients.
5.Patients with coagulopathies, bradycardia, heart blocks, pregnant and nursing women.
6.Patients unwilling to give consent for this study.
7.Patients allergic to the drugs or to the drug group. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COMPARE EFFICACY OF TWO DRUGS FOR CESSATION OF POST SPINAL ANAESTHESIA SHIVERING WITH LEAST SIDE EFFECTS AND BEST EFFICACY |
FROM THE START OF SHIVERING TILL CESSATION OF SHIVERING |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EFFECTS OF THE STUDY DRUGS ON HAEMODYNAMICS,SEDATION ETC |
INTRAOPERATIVE AND POST-OPERATIVE PERIOD |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/03/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PURPOSE OF THE STUDY - TO COMPARE EFFECT OF TRAMADOL AND DEXMEDETOMIDINE ON POST SPINAL ANAESTHESIA SHIVERINGTRAMADOL IS THE DRUG ROUTINELY USED FOR TREATING SHIVERING BUT IS USUALLY ASSOCIATED WITH NAUSEA AND VOMITING. DEXMEDETOMIDINE HAS LESSER SIDE EFFECTS AND HAS BEEN STUDIED INFERING THAT IT CAN ALSO BE USED FOR TREATMENT OF SHIVERING |