| CTRI Number |
CTRI/2023/02/049787 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
15/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study on comparing drug response of bupivacaine with dexmedetomidine and levobupivacaine with dexmedetomidine(drug name)in spinal anaesthesia for lower limb surgeries-A Randomised Controlled trial |
|
Scientific Title of Study
|
comparative study between intrathecal 0.5% Levobupivacaine with Dexmedetomidine and intrathecal 0.5% Bupivacaine with Dexmedetomidine in elective infraumbilical surgeries-A prospective double blinded Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chowndharryaa Soccalingame |
| Designation |
M.D.Anesthesia-Postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Dept of Anesthesia Ot complex, jr quaters division, Sri venkateshwaraa Medical College Hospital and Research Centre, No 13-A,pondy-villupuram Main Road,Ariyur,Puducherry-605107
No 13-A,pondy-villupuram Main Road,Ariyur,Puducherry-605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9994665452 |
| Fax |
|
| Email |
chowndharryaa96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chinthavali Sujatha |
| Designation |
Associate profesor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Dept of Anesthesia,Ot complex, Sri venkateshwaraa Medical College Hospital and Research Centre, No 13-A,pondy-villupuram Main Road,Ariyur,Puducherry-605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8939012490 |
| Fax |
|
| Email |
sujathachinthavali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chinthavali Sujatha |
| Designation |
Associate professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Dept of Anesthesia,Ot complex, Sri venkateshwaraa Medical College Hospital and Research Centre, No 13-A,pondy-villupuram Main Road,Ariyur,Puducherry-605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8939012490 |
| Fax |
|
| Email |
sujathachinthavali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venkateshwaraa Medical College Hospital and Research Centre, No 13-A,pondy-villupuram Main Road,Ariyur,Puducherry-605107 |
|
|
Primary Sponsor
|
| Name |
Chowndharrya Soccalingame |
| Address |
Sri venkateshwaraa Medical College Hospital and Research Centre, No 13-A,pondy-villupuram Main Road,Ariyur,Puducherry-605107 |
| 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 |
| Chowndharryaa soccalingame |
sri venkateshwaraa medical college Hospital and research center |
department of anaesthesiology, ot complex,surgery and gynaecology division, room no5,pondy-villupuram main road,ariyur,puducherry-605107
Pondicherry
PONDICHERRY |
9994665452
chowndharryaa96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
0.5% Bupivacaine with 50mcg Dexmedetomidine |
Intervention: 0.5% Bupivacaine with 50mcg dexmedetomidine in subarachnoid block in lower limb surgeries.Duration-5minutes |
| Intervention |
SUBARACHNOID BLOCK |
Intervention:0.5%Levobupivacaine with 50mcg dexmedetomidine in subarachnoid block in lower limb surgeries.Duration-5minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18to60yrs
American society of anaesthesiologists class 1 and 2
Patient undergoing elective infraumbilical surgeries |
|
| ExclusionCriteria |
| Details |
Contraindications for neuraxial blockade
Patient converted to general anaesthesia
Any psychiatric illness or on antipsychotic medications |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| O.5%levobupivacaine with 50mcg dexmedetomidine will show onset and prolonged duration of sensory and motor blockade than 0.5%bupivacaine with dexmedetomidine in subarachnoid Block |
Sensory blockade will be assessed by 3point qualitative scale,motor blockade assessed by 3point qualitative scale, Post operative pain assessed by visual analogue scale at 0min,3min,6min,9min,12min,15min,30min,45min,60min,90min,120min,6hrs,12hrs,24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| O.5%bupivacaine with 50mcg dexmedetomidine will show lesser onset and duration of sensory and motor blockade than 0.5%levobupivacaine with 50mcg dexmedetomidine in subarachnoid block |
Sensory blockade will be assessed by 3point qualitative scale,motor blockade assessed by 3point qualitative scale, Post operative pain assessed by visual analogue scale at 0min,3min,6min,9min,12min,15min,30min,45min,60min,90min,120min,6hrs,12hrs,24hrs |
|
|
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)
|
28/02/2023 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to compare levobupivacaine with dexmedetomidine and bupivacaine with dexmedetomidine in subarachnoid block for elective lower limb surgeries.my study thesis is levobupivacaine with dexmedetomidine will show onset and prolonged duration of sensory and motor blockade than bupivacaine with dexmedetomidine |