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Clinical Trials/NCT05224167
NCT05224167
Unknown
Not Applicable

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

Mongi Slim Hospital0 sites50 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Melatonin 5 MG Sublingual Tablet
Conditions
Preoperative Anxiety
Sponsor
Mongi Slim Hospital
Enrollment
50
Primary Endpoint
preoperative anxiety
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
July 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mhamed Sami Mebazaa

Professor head of anesthesia and intensive care department

Mongi Slim Hospital

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

Arms & Interventions

Group A

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

Intervention: Melatonin 5 MG Sublingual Tablet

Group B

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

Intervention: Hydroxyzine

Outcomes

Primary Outcomes

preoperative anxiety

Time Frame: 1 hour before surgery

preoperative anxiety scale

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