Preoperative Anxiety
Conditions
Keywords
Melatonin, Hydroxizin, Hip fracture
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
Interventions
DRUGMelatonin 5 MG Sublingual Tablet
Melatonin 5 mg 12 hours and 2 hours prior to surgery
DRUGHydroxyzine
Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery
Sponsors
Mongi Slim Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* All adult patients scheduled for hip fracture surgery
Exclusion criteria
* Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| preoperative anxiety | 1 hour before surgery | preoperative anxiety scale |
Contacts
Primary ContactMhamed Sami Mebazaa, Prof
Backup ContactAsma Ben Souissi, Assoc Prof
Outcome results
None listed