| CTRI Number |
CTRI/2024/01/062086 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
To compare duration of pain control between different doses of clonidine with bupivacaine in spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of Sensory and Motor Characteristics Between Two Low Doses of Clonidine as Adjuvant to Hyperbaric Bupivacaine versus Plain Hyperbaric Bupivacaine for Spinal Anesthesia Among Patients Undergoing Infra Umbilical Surgeries |
| 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 Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical sciences |
| Address |
Department of Anesthesiology
Mandya Institute of Medical sciences
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
7892877646 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical sciences |
| Address |
Department of Anesthesiology
Mandya Institute of Medical sciences
Mandya
KARNATAKA
571401
India |
| Phone |
7892877646 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical sciences |
| Address |
Department of Anesthesiology
Mandya Institute of Medical sciences
Mandya
KARNATAKA
571401
India |
| Phone |
7892877646 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of Medical sciences |
|
|
Primary Sponsor
|
| Name |
Dr Santhosh M C B |
| Address |
Associate professor
Department of Anesthesiology
Mandya Institute of Medical sciences
Mandya |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Akshay C |
Post graduate student
Department of Anesthesiology
Mandya Institute of Medical sciences
Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshay C |
Mandya Institute of Medical sciences |
Department of Anesthesiology
Mandya Institute of Medical sciences
Mandya
Mandya
KARNATAKA |
9886778009
akshaychandra97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, MIMS, Mandya |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
BMI of 18.5 to 24.9 kg per meter square |
|
| ExclusionCriteria |
| Details |
Patients allergic to study drugs
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of analgesia between the groups |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare hemodynamic parameters between the groups
To compare adverse events between the groups |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
01/02/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is designed to compare efficacy between patients receiving either bupivacaine plus 7.5mcg clonidine or bupivacaine plus 15mcg clonidine in patients undergoing infra umbilical surgeries under spinal anaesthesia in terms of duration of spinal anaesthesia both sensory and motor blockade, duration of analgesia, hemodynamic parameters and adverse events between the groups. |