Main
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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:
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CTRI |
Last refreshed on:
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25 July 2023 |
Main ID: |
CTRI/2023/06/054491 |
Date of registration:
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27-06-2023 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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To evaluate weather we can use perfusion index to know the onset of caudal block in children undergoing lower abdominal surgeries
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Scientific title:
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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:
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05-07-2023 |
Target sample size:
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40 |
Recruitment status: |
Not Yet Recruiting |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=87958 |
Study type:
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Observational |
Study design:
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Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Madhu Dayal
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Address:
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Department of Anaesthesia, Ground floor Main OT complex , VMMC and Safdarjung hospital, New Delhi
110029
South, DELHI
India |
Telephone:
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9811271996 |
Email:
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drmadhudayal@gmail.com |
Affiliation:
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VMMC AND SAFDARJUNG HOSPITAL |
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Name:
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Dr Madhu Dayal
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Address:
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Department of Anaesthesia, Ground floor Main OT complex , VMMC and Safdarjung hospital, New Delhi
110029
South, DELHI
India |
Telephone:
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9811271996 |
Email:
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drmadhudayal@gmail.com |
Affiliation:
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VMMC AND SAFDARJUNG HOSPITAL |
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Key inclusion & exclusion criteria
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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:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: 4- Measurement and Monitoring
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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heart rate & MAP
Timepoint: precaudal baseline postcaudal block at 5 minute 10 minute 15 minute 20 minute at skin incision
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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
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Temperature in both upper & lower limbTimepoint: precaudal baseline postcaudal block at 5 minute 10 minute 15 minute 20 minute at skin incision
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Source(s) of Monetary Support
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Vardhman Mahavir medical college and Safdarjung hospital ,Ansari Nagar, New Delhi 110029
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Ethics review
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Status: Approved
Approval date: 27/03/2023
Contact:
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI , INSTITUTIONAL ETHICS COMMITTEE
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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