Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
NCT ID: NCT05224167
Last Updated: 2022-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-03-01
2022-07-30
Brief Summary
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Detailed Description
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Non inclusion criteria: patients with severe cognitive impairement Primary outcome pre operative anxiety assessed with Amsterdam preoperative anxiety and information scale
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Group A
patients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery
Melatonin 5 MG Sublingual Tablet
Melatonin 5 mg 12 hours and 2 hours prior to surgery
Group B
patients of this group will receive 1 mg/kg of Hydroxizin 12 hours and 1 mg/ kg 2 hours prior to surgery
Hydroxyzine
Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery
Interventions
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Melatonin 5 MG Sublingual Tablet
Melatonin 5 mg 12 hours and 2 hours prior to surgery
Hydroxyzine
Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Mongi Slim Hospital
OTHER
Responsible Party
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Mhamed Sami Mebazaa
Professor head of anesthesia and intensive care department
Central Contacts
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Other Identifiers
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Melatonin versus Hydroxizin
Identifier Type: -
Identifier Source: org_study_id
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