| CTRI Number |
CTRI/2018/03/012732 [Registered on: 22/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare Tramadol and Dexmedetomidine in the treatment of shivering after spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of tramadol and dexmedetomidine in treatment of post neuraxial anaesthesia shivering |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Bansal |
| Designation |
Post Graduate |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no. 1, B block, Department of Anaesthesia, Peoples College of Medical Sciences and Research Centre
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8435641574 |
| Fax |
|
| Email |
akki.shine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhilekh Jain |
| Designation |
Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no. 1, B block, Department of Anaesthesia, Peoples College of Medical Sciences and Research Centre
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9827606268 |
| Fax |
|
| Email |
jainabhilekh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilekh Jain |
| Designation |
Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no. 1, B block, Department of Anaesthesia, Peoples College of Medical Sciences and Research Centre
Sagar
MADHYA PRADESH
462037
India |
| Phone |
9827606268 |
| Fax |
|
| Email |
jainabhilekh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College of Medical Sciences and Research Centre, Bhanpur Road, Bhopal, Madhya Pradesh -462037 |
|
|
Primary Sponsor
|
| Name |
Akanksha Bansal |
| Address |
Room no. 1, B block, Department of Anaesthesia, Peoples College of Medical Sciences and Research Centre |
| 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 Akanksha Bansal |
Peoples Hospital |
Room No.-1,B-block,
Department of Anaesthesia
Peoples College of Medical Sciences and Research Centre, Bhanpur road
Bhopal
MADHYA PRADESH |
8435641574
akki.shine@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
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No Pain |
| Patients |
ASA I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
To control Post spinal anaesthesia shivering within 10 minutes and compare between the drugs |
| Intervention |
Tramadol |
To control Post spinal anaesthesia shivering within 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade I and II
2. Patients admitted for lower abdominal and lower limb surgeries
|
|
| ExclusionCriteria |
| Details |
1. Patients with cardiopulmonary disease, hepatic disorder, respiratory and neurological disorder.
2. Allergy to the study drugs
3. Those with an initial heart rate < 50 beats/minute
4. Systolic blood pressure < 100 mmHg
5. Patient on narcotics or any other sedatives which alter the thermoregulation
6. Patients with recent history of febrile illness and those with history of malignant hyperthermia.
7. Contraindication to regional anaesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| control of shivering |
5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of shivering |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/01/2017 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Shivering after neuraxial blockade should be managed efficiently to reduce its complications. Thus this study would conclude the better drug which can be used in cases of shivering. Also the study will compare the side-effects of the treatment drug and the rate of recurrence after giving the treatment, ultimately reducing the patient discomfort. AIM- The purpose of this study is to compare Dexmedetomidine 0.5 μg/kg with that of Tramadol 0.5 mg/kg, both diluted in 10 ml NS given as IV infusion in 1 minute, in the treatment of shivering in patients undergoing elective surgery under spinal anaesthesia.
OBJECTIVE- 1.To assess the efficacy, potency and side-effects of Tramadol in treatment of shivering 2.To assess the efficacy, potency and side-effects of Dexmedetomidine in treatment of shivering 3.To compare the efficacy, potency and side-effects of both the drugs |