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

NCT ID: NCT05224167

Last Updated: 2022-02-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-07-30

Brief Summary

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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

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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

Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

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

Group Type ACTIVE_COMPARATOR

Melatonin 5 MG Sublingual Tablet

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Hydroxyzine

Intervention Type DRUG

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

Intervention Type DRUG

Hydroxyzine

Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All adult patients scheduled for hip fracture surgery

Exclusion Criteria

* Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mhamed Sami Mebazaa

Professor head of anesthesia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mhamed Sami Mebazaa, Prof

Role: CONTACT

0021622252589

Asma Ben Souissi, Assoc Prof

Role: CONTACT

0021698336883

Other Identifiers

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Melatonin versus Hydroxizin

Identifier Type: -

Identifier Source: org_study_id

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