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Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture

Primary Purpose

Preoperative Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Melatonin 5 MG Sublingual Tablet
Hydroxyzine
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preoperative Anxiety focused on measuring Melatonin, Hydroxizin, Hip fracture

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adult patients scheduled for hip fracture surgery

Exclusion Criteria:

  • Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

    patients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery

    patients of this group will receive 1 mg/kg of Hydroxizin 12 hours and 1 mg/ kg 2 hours prior to surgery

    Outcomes

    Primary Outcome Measures

    preoperative anxiety
    preoperative anxiety scale

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2022
    Last Updated
    January 25, 2022
    Sponsor
    Mongi Slim Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05224167
    Brief Title
    Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
    Official Title
    Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    July 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mongi Slim Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively
    Detailed Description
    prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively Non inclusion criteria: patients with severe cognitive impairement Primary outcome pre operative anxiety assessed with Amsterdam preoperative anxiety and information scale

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preoperative Anxiety
    Keywords
    Melatonin, Hydroxizin, Hip fracture

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    patients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    patients of this group will receive 1 mg/kg of Hydroxizin 12 hours and 1 mg/ kg 2 hours prior to surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Melatonin 5 MG Sublingual Tablet
    Intervention Description
    Melatonin 5 mg 12 hours and 2 hours prior to surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxyzine
    Intervention Description
    Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery
    Primary Outcome Measure Information:
    Title
    preoperative anxiety
    Description
    preoperative anxiety scale
    Time Frame
    1 hour before surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All adult patients scheduled for hip fracture surgery Exclusion Criteria: Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mhamed Sami Mebazaa, Prof
    Phone
    0021622252589
    Email
    msmebazaa@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asma Ben Souissi, Assoc Prof
    Phone
    0021698336883
    Email
    bsouissiasma@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture

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