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

Mongi Slim Hospital

Status: Unknown

Conditions: Preoperative Anxiety

Treatments: Drug: Hydroxyzine; Drug: Melatonin 5 MG Sublingual Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05224167

Melatonin versus Hydroxizin

Details and patient eligibility

About

prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Drug: Melatonin 5 MG Sublingual Tablet

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Hydroxyzine