CClinicalTrials.gg
Status unknownNCT05224167Updated Feb 4, 2022

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

An interventional study of Melatonin 5 MG Sublingual Tablet and Hydroxyzine in Preoperative Anxiety, sponsored by Mongi Slim Hospital. Status unknown. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-02-04.

Sponsored by Mongi Slim Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Preoperative Anxiety

Keywords

  • Melatonin
  • Hydroxizin
  • Hip fracture
03

In context

Hip Fractures

822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 529 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Mongi Slim Hospital is the lead sponsor of 37 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All adult patients scheduled for hip fracture surgery

Exclusion criteria

Exclusion Criteria:

  • Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

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

06

What researchers measure

Primary outcomes

  1. preoperative anxiety

    preoperative anxiety scale

    Time frame: 1 hour before surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05224167
Lead sponsor
Mongi Slim Hospital
Responsible party
Mhamed Sami Mebazaa (Professor head of anesthesia and intensive care department, Mongi Slim Hospital) — Principal investigator
First posted
Feb 4, 2022
Start date
Mar 1, 2022 (estimated)
Primary completion
Jun 30, 2022 (estimated)
Completion
Jul 30, 2022 (estimated)
Last update
Feb 4, 2022

Study contacts

Mhamed Sami Mebazaa, Prof
Contact
msmebazaa@gmail.com
0021622252589
Asma Ben Souissi, Assoc Prof
Contact
bsouissiasma@gmail.com
0021698336883

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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