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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. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201604001595341 |
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Date of registration:
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18/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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subarachnoid block for ex-preterm neonates.
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Scientific title:
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Subarachnoid anesthesia (with and without sedation) versus general anesthesia for ex-preterm neonates undergoing elective infraumbalical surgeries. |
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Date of first enrolment:
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01/03/2016 |
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Target sample size:
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105 |
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Recruitment status: |
Recruiting |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1595 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mostafa
Mansour Houssein |
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Address:
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Department of anesthesia and intensive care, Faculty of Medicine, Ain Shams University
11566
Cairo
Egypt |
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Telephone:
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00201093322145 |
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Email:
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mostafa_mansour361@hotmail.com |
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Affiliation:
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lecturer of anesthesia and intensive care |
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Name:
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Mostafa
Mansour Houssein |
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Address:
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Department of anesthesia and intensive care, Faculty of Medicine, Ain Shams University
11566
Cairo
Egypt |
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Telephone:
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00201093322145 |
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Email:
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mostafa_mansour361@hotmail.com |
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Affiliation:
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lecturer of anesthesia and intensive care |
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Key inclusion & exclusion criteria
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Inclusion criteria: . The age:formerly preterm neonates with post-conceptual age less than 60 weeks.
. operation: infraumbalical surgery.
. ASA: I - II
. Sex: both sexes.
Exclusion criteria: . known allergy to local anesthetics
. coagulopathy
. pre-existing cardiac disease
. metabolic disease
. neuromuscular disease
. uncontrolled convulsion
.local infection at puncture site
.parent refusal
Age minimum:
0 Week(s)
Age maximum:
60 Week(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anaesthesia
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Paediatrics
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Surgery
Paediatrics
Anaesthesia
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Surgery
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Intervention(s)
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Group I
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Group II
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Group III
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Primary Outcome(s)
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postoperative apnea, postoperative bradycardia and SPO2.
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Secondary Outcome(s)
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The secondary outcome measures were postoperative complications (e.g. hypotension) and the need for postoperative respiratory support.
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Source(s) of Monetary Support
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Faculty of Medicine, Ain Shams University
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Ethics review
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Status: Approved
Approval date: 13/04/2016
Contact:
Faculty of Medicine, Ain Shams University.
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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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