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

Sponsor
Mongi Slim Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05224167
Collaborator
(none)
50
2
5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

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

Drug: Melatonin 5 MG Sublingual Tablet
Melatonin 5 mg 12 hours and 2 hours prior to surgery

Active Comparator: Group B

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

Drug: Hydroxyzine
Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery

Outcome Measures

Primary Outcome Measures

  1. preoperative anxiety [1 hour before surgery]

    preoperative anxiety scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mongi Slim Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mhamed Sami Mebazaa, Professor head of anesthesia and intensive care department, Mongi Slim Hospital
ClinicalTrials.gov Identifier:
NCT05224167
Other Study ID Numbers:
  • Melatonin versus Hydroxizin
First Posted:
Feb 4, 2022
Last Update Posted:
Feb 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mhamed Sami Mebazaa, Professor head of anesthesia and intensive care department, Mongi Slim Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2022