| CTRI Number |
CTRI/2022/03/041377 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
15/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of IV Dexmedetomidine and IV Tramadol on post spinal anaesthesia shivering. |
|
Scientific Title of Study
|
A Randomized,double Blind,Interventional Study to Compare Intavenous Dexmedetomidine versus Tramadol for Post spinal Anaesthesia Intra Operative Shivering at SMS Hospital,Jaipur during 2021-23 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Chand Modi |
| Designation |
Associate Professor |
| Affiliation |
Department of anaesthesiology,Sawai man singh medical college and attached hospital, jaipur |
| Address |
Department of anaesthesiology,Sawai man singh medical college and attached hospital,adarsh nagar ,jaipur,rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414342614 |
| Fax |
|
| Email |
drmodi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Chand Modi |
| Designation |
Associate Professor |
| Affiliation |
Department of anaesthesiology,Sawai man singh medical college and attached hospital, jaipur |
| Address |
Department of anaesthesiology,Sawai man singh medical college and attached hospital,adarsh nagar ,jaipur,rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414342614 |
| Fax |
|
| Email |
drmodi22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Bharati |
| Designation |
junior resident |
| Affiliation |
sawai man singh medical college and attached hospital, jaipur |
| Address |
Department of anaesthesiology,Sawai man singh medical college and attached hospital,adarsh nagar ,jaipur,rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7742343665 |
| Fax |
|
| Email |
bhartipooja0000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, sawai man singh medical college and attached hospitals, jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology sawai man singh medical college and attached hospitals |
| Address |
JLN marg, Adarsh nagar , jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 Yogesh Chand Modi |
sms medical college |
department of anaesthesiology, 2nd floor , dhanvantri block, sawai man singh medical college and attached hospitals, adarsh nagar, jaipur , rajasthan
Jaipur
RAJASTHAN |
9414342614
drmodi22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS medical college and attached hospital, jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: S723||Fracture of shaft of femur, (5) ICD-10 Condition: N950||Postmenopausal bleeding, (6) ICD-10 Condition: K605||Anorectal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj dexmedetomidine |
group A- patients will receive inj dexmedetomidine 0.5mcg/kg i.v. diluted to 50 ml saline over 10 minutes in case of occurence of shivering intraoperatively
|
| Comparator Agent |
Inj tramadol |
Group B-patients will receive inj tramadol 0.5mg/kg i.v. diluted to 50 ml saline over 10 minutes in case of occurance of shivering intraoperatively |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
.height > and equal to 145 cm
.weight 40 - 80 kgs
.patient who will give written informed consent to participate in the study
.ASA Grade I -II
develop shivering intraoperative under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
.all contraindication to spinal block
.pregnancy
.chronic history of headache and backache
.spinal deformity or infection at the local site
.patient allergic to drug
.failed spinal block/patient refusal
.patient with coagulopathy |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean/median duration for cessation of shivering |
3min, 5 min, 10 min and 15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.proportion of case with reappearance of shivering
.sedation score
.proportion of cases with side effect |
1 hr |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2022 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shivering is known to be a frequent complication in patients undergoing surgery under spinal anaesthesia which if not prevented can have detrimental effect on the patient . So by this study we want to find out an effective drug which decreases post spinal anaesthesia intraoperative shivering in patients.
|