| CTRI Number |
CTRI/2020/01/023040 [Registered on: 30/01/2020] Trial Registered Prospectively |
| Last Modified On: |
28/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
" To compare the efficacy and safety of tramadol and dexmedetomidine in control of post spinal shivering." |
|
Scientific Title of Study
|
“A Comparative Study of Dexmedetomidine and Tramadol for prevention of post-spinal 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 Jay Kavad |
| Designation |
2nd year Resident |
| Affiliation |
GMC Bhavnagar |
| Address |
Department of aneasthesia , Sir T Hospital bhavnagar .
Department of aneasthesia , Sir T Hospital bhavnagar .
Bhavnagar
GUJARAT
364001
India |
| Phone |
8460823304 |
| Fax |
|
| Email |
ahirjash146@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Shah |
| Designation |
Associate Proffessor |
| Affiliation |
GMC Bhavnagar |
| Address |
Department of Aneasthesia , GMC Bhavnagar .
Department of Aneasthesia , GMC Bhavnagar .
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Shah |
| Designation |
Associate Proffessor |
| Affiliation |
GMC Bhavnagar |
| Address |
Department of Aneasthesia , GMC Bhavnagar .
Department of Aneasthesia , GMC Bhavnagar .
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment medical college Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Goverment medical college bhavnagar |
| Address |
Sir T hospital , jail road Bhavnagar . |
| Type of Sponsor |
Government medical college |
|
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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 Jay Kavad |
Sir T hospital , Bhavnagar |
Aneasthesia department ,Sir T Hoapital
Bhavnagar
GUJARAT |
918460823304
ahirjash146@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
“ Tramadol for prevention of post-spinal anaesthesia shivering .†|
A uses of Tramadol(0.5mg/kg) for prevention of post-spinal anaesthesia (10min before give spinal anesthesia)shivering in patient under going elective lower abdominal , lower limb, gynaecological procedures as well as caesarean section , orthopaedic and plastic surgeries under spinal anaesthesia included in the study (observed till 45 min all vital and other side effects) . |
| Comparator Agent |
“Dexmedetomidine for prevention of post-spinal anaesthesia shivering .†|
A uses of Dexmedetomidine (0.5mcg) for prevention of post-spinal anaesthesia (10min before give spinal anesthesia)shivering in patient under going elective lower abdominal , lower limb, gynaecological procedures as well as caesarean section , orthopaedic and plastic surgeries under spinal anaesthesia included in the study (observed till 45 min all vital and sedation of patient). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Informed written consent for participation in study.
Age: 18 to 65 years.
Gender: Either gender.
Patients with haemodynamic HR >60/min , SBP>100 mmHg , after atleast 15 minutes of administering spinal anaesthesia .
Patients scheduled for elective lower abdominal, lower limb, gynaecological procedures as well as caesarean section , orthopedics and plastic surgeries under spinal anaesthesia included in the study .
ASA physical status I ,II & III.
|
|
| ExclusionCriteria |
| Details |
Patients with known hypersensitivity to dexmedetomidine or tramadol .
ASA physical status IV and above.
History of drug allergy (local anaesthetics).
Patients on anticoagulants.
History of bleeding disorders.
Psychiatric illness &Uncooperative patients.
Any major systemic illness like hypertension, heart block etc.
Patients with cardio pulmonary , renal and hepatic disease .
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of onset of shivering (10 minutes intervals) , after given spinal anesthesia
Severity of shivering
• Time to disappearance of shivering (s)
• Time of recurrence (min)
|
Time of onset of shivering (10minutes intervals) , after given spinal anesthesia
Severity(grading) of shivering
• Time to disappearance of shivering (minute)
• Time of recurrence (min)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of surgery (min)
Duration of spinal anaesthesia (min)
• Comparison of shivering grade of both groups
• Comparison of sedation score of both groups
• Intraoperative monitoring parameter in term of Heart rate, Mean arterial pressure, spo2
• Surgeon’s satisfaction score.
• Patient’s satisfaction score. |
12 month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/02/2020 |
| 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="0"
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)?
|
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Brief Summary
|
- Dexmedetomidine effectively controls shivering and takes almost the same time for cessation of shivering as that of tramadol.
- It provides additional benefit of intraoperative sedation without any incidence of nausea and vomiting.
- The recurrence of shivering will more with tramadol.
|