| CTRI Number |
CTRI/2024/08/071836 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effect of three drugs, dexmedetomidine, ketamine and tramadol in patient experiencing shivering during Spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of Dexmedetomedine, Ketamine, and Tramadol In Treatment of Shivering During spinal anaesthesia. |
| 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 Kalavathi |
| Designation |
Junior resident |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research centre |
| Address |
Department of anaesthesiology, ground floor ot complex, sapthagiri hospital
15,Hessarghatta road,Navy layout chikkasandra, Chikkabanavara
Karnataka 560090
Department of anaesthesiology, ground floor ot complex, sapthagiri hospital
15,Hessarghatta road,Navy layout chikkasandra, Chikkabanavara
Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
8904323469 |
| Fax |
|
| Email |
kalavatijat99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sr Shreyavathi . R |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research centre |
| Address |
Department of anaesthesiology, ground floor ot complex, sapthagiri hospital
15,Hessarghatta road,Navy layout chikkasandra, Chikkabanavara
Karnataka 560090
Department of anaesthesiology, ground floor ot complex, sapthagiri hospital
15,Hessarghatta road,Navy layout chikkasandra, Chikkabanavara
Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
9880588325 |
| Fax |
|
| Email |
Shreyamurthy8993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreyavathi . R |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research centre |
| Address |
Department of anaesthesiology, ground floor ot complex, sapthagiri hospital
15,Hessarghatta road,Navy layout chikkasandra, Chikkabanavara
Karnataka 560090
Department of anaesthesiology, ground floor ot complex, sapthagiri hospital
15,Hessarghatta road,Navy layout chikkasandra, Chikkabanavara
Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
9880588325 |
| Fax |
|
| Email |
Shreyamurthy8993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri hospital
15, Hesarghatta rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
15, Hesarghatta road, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090 |
| Type of Sponsor |
Private 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 |
| Kalavathi |
sapthagiri institute of medical sciences and research centre |
Department of anaesthesiology ground floor ot complex , sapthagiri hospital
hesarghatta main road,chikkabanavara, bangalore 560090
Bangalore
KARNATAKA |
9980205851
kalavatijat99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (2) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare the effectiveness of three different drugs dexmedetomidine , ketamine and tramadol in treatmeant of shivering during spinal anaesthesia. |
The study is conducted to known Effectiveness of
Inj Dexmedetomidine dose 0.5 mcg per kg IV or
Inj Ketamine dose 0.5 mg per kg IV or
INJ tramadol dose 0.5 mg per kg IV
the study drug is given iv slowly for over 10mins once the shivering starts post spinal anaesthesia.
patients are divided into Three groups
Group A Dexmedetomidine (60 patients)
Group B Ketamine (60 patients)
Group C Tramadol (60 patients)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to take part in the study
2.Patient posted for elective spinal anaesthesia
3.ASA grade 1&2
4.Age 18 to 60 |
|
| ExclusionCriteria |
| Details |
1.Patient not willing to take part in the study
2.Any abnormalities of spine , kyphosis , lordosis , scoliosis.
3.Bleeding disorder like Haemophilia(A,B), Von-Willebrands, platelet function disorders, Thrombocytopenia, Vitamin K deficiency , Severe liver diseases
4.Patient allergic to to the intended study drug i,e Dexmedetomidine, ketamine , tramadol.
5.Pregnant females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of three drugs dexmedetomidine, ketamine, tramadol in treating the shivering experienced by patients during spinal anaesthesia |
From the time of Spinal anaesthesia given to the patient to 120 minutes at a time interval of 0 mins ,15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for cessation of shivering after the administration of study drug Iv dexmedetomidine or ketamine or tramadol. sedation score (ramsay sedation score) will be monitored, heart rate , blood pressure will be monitored for any changes. |
Time taken for cessation of shivering after the study drug is given. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
12/08/2024 |
| 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="1"
Months="6"
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
|
Patient fullfilling the inclusion criteria will be assessed . Subarachnoid block will be given, patient will be assessed for onset of shivering post spinal 0,15,30,45,60,90,120 mins, study drug will be administered once shivering sets in GRADE 3& 4 shivering score ,time taken for cessation of shivering after administration of drug will be assessed. |