| CTRI Number |
CTRI/2024/05/068106 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Measuring the change in brain pressure in children by ultrasound eye examination after giving different volumes of anaesthesia drug in caudal block |
|
Scientific Title of Study
|
Effect of different local anaesthetic volumes in caudal blocks on intracranial pressure measured indirectly via optic nerve sheath diameter in paediatric patients. |
| 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 Mamta jain |
| Designation |
Associate Professor |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of anaesthesiology and critical care, Pt.B.D.Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9958437432 |
| Fax |
|
| Email |
mamtajainsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta jain |
| Designation |
Associate Professor |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of anaesthesiology and critical care, Pt.B.D.Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9958437432 |
| Fax |
|
| Email |
mamtajainsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDeepali |
| Designation |
Junior resident |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of anaesthesiology and critical care, Pt.B.D.Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9053379969 |
| Fax |
|
| Email |
drdeepali2410@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care,Pt BD Sharma PGIMS Rohtak ,Haryana 124001 India |
|
|
Primary Sponsor
|
| Name |
Pt.B.D.Sharma University of Health and Sciences PGIMS Rohtak Haryana |
| Address |
Pt.B.D.Sharma University of Health and Sciences PGIMS Rohtak Haryana |
| Type of Sponsor |
Government 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 |
| Dr Mamta jain |
Pt.B.D Sharma PGIMS Rohtak |
Department of anaesthesiology and critical care, Pt.B.D Sharma PGIMS Rohtak
Rohtak
HARYANA |
9958437432
mamtajainsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee Pt B D Sharma PGIMS/UHS, Rohtak |
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 |
Low volume group 0.75 ml/kg of Local anaesthetics drug |
In low volume group 1.5mg/kg of bupivacaine will be diluted in NS to make final volume to 0.75 ml/kg and given in caudal space after correct identification of needle placement at the rate of 0.5ml/second. |
| Comparator Agent |
high volume group 1.25ml/kg of local anaesthetic drug used in caudal block |
In high volume group 1.5mg/kg of bupivacaine will be diluted in NS to make final volume to 1.25 ml/kg and given in caudal space after correct identification of needle placement at the rate of 0.5ml/second |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
4.00 Year(s) |
| Gender |
Both |
| Details |
Sixty patients of either sex ,aged 1to4 years of ASA 1or2 scheduled for elective urogenital , inguinal and anorectal surgeries. |
|
| ExclusionCriteria |
| Details |
Patients with refusal to consent,local site infection,coagulopathy,anatomical malformation,allergic to LA,increase in ICP,ophthalmic disease,weight more than 16 kg,short duration surgeries (less than 30 minutes),patent anterior fontanelle |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To meausre the change in ONSD on using two different volumes of LA in caudal block |
Before and immediately after administration of caudal block,5,10,20,and 30 minutes after caudal block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By using two different volumes of LA we measure time taken for maximum increase in ONSD after caudal block administration |
Before and immediately after administration of caudal block,5,10,20,and 30 minutes after caudal block |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
15/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present prospective study will be conducted in the department of anaesthesia and critical care ,PGIMS, Rohtak.Written informed consent will be taken from patients included.The study is to investigate the effect of two different volumes (0.75ml/kg and 1.25ml/kg) of local anaesthetic in caudal block on intracranial pressure measured indirectly using ONSD by ultrasonography in paediatric patients. |