| CTRI Number |
CTRI/2023/08/057050 [Registered on: 29/08/2023] Trial Registered Prospectively |
| Last Modified On: |
27/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of dexmeditomidine with combination of bupivacaine in paediatric caudal anaesthesia |
|
Scientific Title of Study
|
Comparison of two different dosage of dexmeditomidine with bupivacaine in paediatric caudal Anaesthesia for infraumbilical surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BGeetha Sindhuja |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9492659773 |
| Fax |
|
| Email |
sindhugeetha8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeta Chaudhary |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia
Jawaharlal Nehru Medical College
Sawangi(Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
878837832 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeta Chaudhary |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia
Jawaharlal Nehru Medical College
Sawangi(Meghe)
MAHARASHTRA
442001
India |
| Phone |
878837832 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesia
Datta Meghe Institute of Higher Education and Research |
| 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 |
| BGeetha Sindhuja |
Jawaharlal Nehru Medical College |
Department of Anaesthesia
Wardha
MAHARASHTRA |
9492659773
sindhugeetha8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, (2) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine 1mcg/kg will be used as intervention |
In intervention group we will assess the effect of 1 mcg/kg dose of dexmedetomidine with bupivacaine in pediatric caudal block surgeries |
| Comparator Agent |
dexmedetomidine 0.5 mcg/kg will be used as comparitive agent. |
In comparitive group dexmedetomidine 0.5 mcg/kg will be used. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 6 months to 6 years
ASA Class I & II patients.
Children posted for infraumbilical surgeries
|
|
| ExclusionCriteria |
| Details |
ASA grade 3, 4 and 5.
allergy to any of the study drug
Cardiac, Respiratory diseases
Hepatic, Renal dysfunction
developmental delay or mental retardation
Infection at the site of caudal block.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caudal dexmeditomidine (1mcg/kg) with 0.25% bupivacaine for paediatric infra umbilical surgeries achieved significant post operative pain relief compared to caudal dexmeditomidine (0.5mcg/kg) with 0.25% bupivacaine. |
240 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of side effects was less in 0.5 mcg/kg dexmeditomidine group when compared to 1mcg/kg group |
240 minutes |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Caudal epidural block is one of the most common regional techniques in paediatric anesthesia .Caudal block is a safe and reliable technique, easy to perform and has been foundto be very effective in children,we will conduct this study to compare two different dosages, 1μg/kg dexmedetomidine with bupivacaine during caudal epidural block which has been proved to increase analgesia duration in comparison with 0.5μg/kg dexmedetomidine as an adjuvant for duration of postoperative analgesia ,hemodynamic changes and adverse effects. |