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

Not Applicable

• Conditions: Preoperative Anxiety
• Interventions: Drug: Melatonin 5 MG Sublingual Tablet; Drug: Hydroxyzine

• Registration Number: NCT05224167
• Lead Sponsor: Mongi Slim Hospital

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

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-01-25
• Last Update Submitted: 2022-01-25
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04
• Study Start: 2022-03-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All adult patients scheduled for hip fracture surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Melatonin 5 MG Sublingual Tablet	patients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery
Group B	Hydroxyzine	patients of this group will receive 1 mg/kg of Hydroxizin 12 hours and 1 mg/ kg 2 hours prior to surgery

Primary Outcome Measures

Name	Time	Method
preoperative anxiety	1 hour before surgery	preoperative anxiety scale