| CTRI Number |
CTRI/2025/05/086136 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing effects of clonidine versus dexmedetomidine with bupivacaine via caudal block to prolong postoperative analgesia in children undergoing below umbilical surgeries. |
|
Scientific Title of Study
|
Comparison of caudal clonidine versus caudal dexmedetomidine with bupivacaine for prolongation of postoperative analgesia in children undergoing infraumbilical 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 |
NIRMALKUMAR MISTRY |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
B.J. MEDICAL COLLEGE AHMEDABAD |
| Address |
F3 ANAESTHESIOLOGY DEPARTMENT, CIVIL HOSPITAL AND B.J. MEDICAL COLLEGE, ASARWA, AHMEDABAD
PHASE -1,E-109, PG HOSTEL,CIVIL HOSPITAL,ASARWA
Ahmadabad
GUJARAT
380016
India |
| Phone |
7698300106 |
| Fax |
|
| Email |
nirmalmistry18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NILESH M SOLANKI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
B.J. MEDICAL COLLEGE AHMEDABAD |
| Address |
F3, DEPARTMENT OF ANAESTHESIA, BJ MEDICAL COLLEGE AND HOSPITAL,ASARWA
Ahmadabad
GUJARAT
380016
India |
| Phone |
9998991716 |
| Fax |
|
| Email |
nmscbaps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NIRMALKUMAR MISTRY |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
B.J. MEDICAL COLLEGE AHMEDABAD |
| Address |
F3, DEPARTMENT OF ANAESTHESIA, BJ MEDICAL COLLEGE AND HOSPITAL,ASARWA
Ahmadabad
GUJARAT
380016
India |
| Phone |
07698300106 |
| Fax |
|
| Email |
nirmalmistry18@gmail.com |
|
|
Source of Monetary or Material Support
|
| F3, DEPARTMENT OF ANAESTHESIA, B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL, ASARWA, AHMEDABAD, INDIA- 380016 |
|
|
Primary Sponsor
|
| Name |
NIRMALKUMAR MISTRY |
| Address |
F3, B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL ,ASARWA,AHMEDABAD |
| 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 |
| NIRMALKUMAR MISTRY |
CIVIL HOSPITAL, ASARWA, AHMEDABAD |
F3, DEPARTMENT OF ANAESTHESIA,BJ MEDICAL COLLEGE ,ASARWA, AHMEDABAD- 380016
Ahmadabad
GUJARAT |
7698300106
nirmalmistry18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL AHMEDABAD |
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 |
| Intervention |
CAUDAL EPIDURAL INJECTION OF BUPIVACAINE WITH CLONIDINE IN CHILDREN UNDERGOING INFRAUMBILICAL SURGERIES. |
DOSE-BUPIVACAINE(0.25%) 1ML/KG (AS PAR ARMITAGE FORMULA)+ CLONIDINE 1MCG/KG DOSAGE FOR CAUDAL BLOCK, MAXIMUM TOTAL VOLUME OF 12ML . |
| Comparator Agent |
CAUDAL EPIDURAL INJECTION OF BUPIVACAINE WITH DEXMEDETOMIDINE IN CHILDREN UNDERGOING INFRAUMBILICAL SURGERIES. |
DOSE-BUPIVACAINE(0.25%) 1ML/KG (AS PAR ARMITAGE FORMULA)+ DEXMEDETOMIDINE 1MCG/KG DOSAGE FOR CAUDAL BLOCK, MAXIMUM TOTAL VOLUME OF 12ML . |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA I ,II AND III
PATIENTS SCHEDULED FOR INFRA-UMBILICAL SURGERIES
ELECTIVE SURGERIES.
CONSENT FROM LEGALLY AUTHORIZED REPRESENTATIVE
|
|
| ExclusionCriteria |
| Details |
ASA IV AND V
PARENTS AND PATIENT RELATIVE REFUSING TO GIVE CONSENT
PATIENTS HAVING PRE-EXISTING CARDIAC, NEUROLOGICAL AND RESPIRATORY DISEASES
PATIENTS HAVING COAGULOPATHY
PATIENTS WITH CONGENITAL SPINE ANOMALY
LOCAL INFECTION/INFLAMMATION.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.TO COMPARE DURATION OF ANALGESIA IN BOTH GROUP.
2.TO STUDY POSTOPERATIVE PAIN RELIEF IN BOTH GROUP.
|
24 HR POST OPERATIVE ASSESSMENT OF PAIN RELIEF SCORE.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.INTRAOPERATIVE HEMODYNAMIC PARAMETERS.
2.TO COMPARE INTRA OPERATIVE AND POSTOPERATIVE COMPLICATIONS RELATED TO DRUG AND COMPLICATION ASSOCIATED WITH TECHNIQUE.
3.TO COMPARE LEVEL OF SEDATION (RAM SAY SEDATION SCORE)
|
INTRAOPERATIVE HEMODYNAMIC PARAMETER TILL SURGERY COMPLETED.
24 HR POST OPERATIVE ASSESSMENT OF SEDATION SCORE & COMPLICATION ASSOCIATED WITH TECHNIQUE AND DRUG.
|
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| 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="0"
Months="6"
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
|
Bupivacaine is a long acting amide local anaesthetic. It is
most frequently used for caudal anaesthesia in children that provides effective
analgesia and motor blockade.Clonidine has been used for sedation,
premedication and analgesia.Dexmedetomidine is a potent alpha 2 agonist
(selective 2a subtype), widely used to provide analgesia, sedation and
anxiolysis.Studies show increase in duration of post-operative analgesia on
adding clonidine & dexmedetomidine
to local anaesthetic. Both are a safe adjuvant to bupivacaine in pediatric
caudal anaesthesia.We therefore decided to study the effects of combination of
Bupivacaine and clonidine for prolongation of post-operative analgesia in
children were evaluated and compared with the effect of combination of
bupivacaine and Dexmedetomidine for prolongation of post-operative analgesia.
Hemodynamic changes and side effects was
also compared between both group, in children undergoing lower abdominal and
perineal surgeries.
|