| CTRI Number |
CTRI/2024/05/067831 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pre-treatment in prevention of post spinal shivering with oral gabapentin and oral tramadol. |
|
Scientific Title of Study
|
Efficacy of Oral Gabapentin vs Oral Tramadol Pretreatment in prevention of post spinal shivering- A Randomised controlled trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lovepreet Singh |
| Designation |
Post graduate trainee |
| Affiliation |
Kalinga Institute of Medical Sciences (KIMS) |
| Address |
Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9878930294 |
| Fax |
|
| Email |
2387010@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lingaraj Sahu |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical Sciences (KIMS) |
| Address |
Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8281066501 |
| Fax |
|
| Email |
lingaraj.Sahu@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lingaraj Sahu |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical Sciences (KIMS) |
| Address |
Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8281066501 |
| Fax |
|
| Email |
lingaraj.Sahu@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences (KIMS)
Department of anesthesiology, 3rd floor ,PBMH , KIMS,KIIT University, Bhubaneswar
Khordha ORISSA 751024
India
|
|
|
Primary Sponsor
|
| Name |
Dr Lovepreet Singh |
| Address |
Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneswar, Odisha, 751024
|
| 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 Lingaraj Sahu |
Kalinga Institute of Medical Sciences, Bhubaneswar |
Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneswar 751024
Khordha
ORISSA |
8281066501
lingaraj.Sahu@kims.ac.in |
|
|
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 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pretreatment with oral Gabapentin |
Will receive Tab Gabapentin of 300 mg orally 2 hours before surgery with a sip of water to prevent post spinal shivering intraoperatively for 2-6 hours. |
| Comparator Agent |
Pretreatment with oral Tramadol |
Will receive Tab Tramadol of 100 mg orally 2 hours before surgery with a sip of water to prevent post spinal shivering intraoperatively for 2-6 hours . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years
2.American Society of Anaesthesiologists (ASA) I AND II
3.Elective surgery under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1.History of allergy to opioids and gabapentin
2.Patient already on tramadol and gabapentin 3.History of opioids abuse
4.Febrile patient
5.Patient with psychiatric illness or communication difficulty
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the onset of shivering after spinal anaesthesia between the groups |
for 2-4 hours after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the severity of shivering
2.To observe the therapeutic dose of fentanyl to control shivering
|
Intra operative for 2-4 hours |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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 4 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 a common complication after subarachnoid block with a reported incidence of 40 to 50%. Shivering
increases the oxygen demand by 200-500% and can cause various
metabolic changes . Shivering can also lead
to compromised myocardial and pulmonary functions. Tramadol is the most commonly used drug with less side effects. Newer alternate drugs like Gabapentin are currently being investigated for its role in prevention of post -spinal
shivering . The present study is planned to compare premedication with oral gabapentin and oral tramadol for
prophylaxis of post-spinal shivering. |