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NCT05224167 Clinical Trial

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

Preoperative Anxiety Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05224167
Other study ID # Melatonin versus Hydroxizin
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date July 30, 2022

Study information
Verified date January 2022
Source Mongi Slim Hospital
Contact Mhamed Sami Mebazaa, Prof
Phone 0021622252589
Email msmebazaa@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date July 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Melatonin 5 MG Sublingual Tablet
Melatonin 5 mg 12 hours and 2 hours prior to surgery
• Hydroxyzine
Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mongi Slim Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary preoperative anxiety preoperative anxiety scale 1 hour before surgery
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