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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 25 July 2023
Main ID:  CTRI/2023/06/054491
Date of registration: 27-06-2023
Prospective Registration: Yes
Primary sponsor: Vardhan Mahavir medical college and Safdarjung hospital
Public title: To evaluate weather we can use perfusion index to know the onset of caudal block in children undergoing lower abdominal surgeries
Scientific title: Evaluation of perfusion index as a predictor of onset of caudal block in paediatric patients undergoing infraumblical surgery under general anaesthesia - Nil
Date of first enrolment: 05-07-2023
Target sample size: 40
Recruitment status: Not Yet Recruiting
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=87958
Study type:  Observational
Study design:  Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label  
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Dr Madhu Dayal   
Address:  Department of Anaesthesia, Ground floor Main OT complex , VMMC and Safdarjung hospital, New Delhi 110029 South, DELHI India
Telephone: 9811271996
Email: drmadhudayal@gmail.com
Affiliation:  VMMC AND SAFDARJUNG HOSPITAL
Name: Dr Madhu Dayal   
Address:  Department of Anaesthesia, Ground floor Main OT complex , VMMC and Safdarjung hospital, New Delhi 110029 South, DELHI India
Telephone: 9811271996
Email: drmadhudayal@gmail.com
Affiliation:  VMMC AND SAFDARJUNG HOSPITAL
Key inclusion & exclusion criteria
Inclusion criteria: Paediatric patients with age between 3 to 12 years with ASA physical status 1 and 2 and undergoing elective infraumblical and lower limb surgeries
Exclusion criteria: 1. Patients with history of allergy to local anaesthetics.

2. Infection at insertion site.

3. neuromuscular disease.

4. cerebral palsy

5. bleeding disorder


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: 4- Measurement and Monitoring
Intervention(s)
Control Intervention1: Comparing perfusion index with heart rate , MAP , temperature in both upper limb and lover limb.: Well be comparing perfusion index , heart rate , MAP , Temperature to know which of them is most accurate and fast indicator of onset of caudal block. They will be measured at precaudal baseline , and post caudal block at 5 min , 10 min , 15 min , 20 min.
Primary Outcome(s)
To assess the onset of caudal block using serial perfusion index values at precaudal baseline postcaudal block at 5 minute 10 minute 15 minute 20 minute at skin incisionTimepoint: precaudal baseline postcaudal block at 5 minute 10 minute 15 minute 20 minute at skin incision
Secondary Outcome(s)
heart rate & MAP

Timepoint: precaudal baseline postcaudal block at 5 minute 10 minute 15 minute 20 minute at skin incision

Perfusion index in both upper limb & lower limb

Timepoint: precaudal baseline postcaudal block at 5 minute 10 minute 15 minute 20 minute at skin incision

Temperature in both upper & lower limbTimepoint: precaudal baseline postcaudal block at 5 minute 10 minute 15 minute 20 minute at skin incision

Secondary ID(s)
NIL
Source(s) of Monetary Support
Vardhman Mahavir medical college and Safdarjung hospital ,Ansari Nagar, New Delhi 110029
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 27/03/2023
Contact:
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI , INSTITUTIONAL ETHICS COMMITTEE
Results
Results available:
Date Posted:
Date Completed:
URL:
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