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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no additional information available.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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This clinical trial study will be conducted after obtaining the necessary permits and ethical code, and it will assess the effect of dexamethasone on reducing nausea and vomiting after surgery in children undergoing laparoscopic procedures. These patients will be kept NPO (nothing by mouth) for 6 to 8 hours before entering the operating room. They will be randomly assigned to one of the study groups using the Random Allocation software. The random allocation to groups will be carried out by a nurse who is not involved in the study. In the intervention group, children will receive dexamethasone at a dose of 0.15 mg/kg after the induction of anesthesia, while the control group will receive normal saline at the same dose. It is worth noting that the syringes used in both groups will be identical in shape and brand, marked with letters A and B to ensure blinding. The codes will not be revealed until after data analysis. The patient, evaluating physician, and data analyst will be blinded and unaware of group assignments.
After the children enter the operating room, their demographic data, such as age, gender, and ASA score, will be recorded through a checklist.
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When the data will become available and for how long
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Data collection will begin on September 16, 2024, and will conclude on March 15, 2025. After this date, the results will be accessible.
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To whom data/document is available
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This study will be accessible to both people in academic and scientific institutions and people in industry
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Under which criteria data/document could be used
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In order to use the data in studies and other works, it is necessary to coordinate with the person in charge of the research
And only reading is free for the public
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From where data/document is obtainable
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Coordination with the research officer, Dr. Hamidreza Shatabi, or the research affairs of Isfahan University of Medical Sciences
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What processes are involved for a request to access data/document
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Coordination with the research officer, Dr. Hamidreza Shatabi, or the research affairs of Isfahan University of Medical Sciences(email,phone and…)
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Comments
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