NCT05224167

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

January 25, 2022

Last Update Submit

January 25, 2022

Conditions

Preoperative Anxiety

Keywords

MelatoninHydroxizinHip fracture

Outcome Measures

Primary Outcomes (1)

  • preoperative anxiety

    preoperative anxiety scale

    1 hour before surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Melatonin 5 MG Sublingual TabletDRUG

Melatonin 5 mg 12 hours and 2 hours prior to surgery

Group A
HydroxyzineDRUG

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

Group B

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients scheduled for hip fracture surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Interventions

MelatoninAdministration, SublingualHydroxyzine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAdministration, OralDrug Administration RoutesDrug TherapyTherapeuticsPiperazinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Mhamed Sami Mebazaa, Prof

CONTACT

0021622252589msmebazaa@gmail.com

Asma Ben Souissi, Assoc Prof

CONTACT

0021698336883bsouissiasma@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor head of anesthesia and intensive care department

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

March 1, 2022

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

February 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share