Melatonin Versus Hydroxizin for Pre Operative Anxiety in... | NCT05224167

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

NCT05224167

Sponsor

Mongi Slim Hospital

Status

Unknown status

Last Update Posted

Feb 4, 2022Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Preoperative Anxiety

Interventions

Melatonin 5 MG Sublingual Tablet
Hydroxyzine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Estimated

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Jul 30, 2022Estimated

First Submitted Date

Jan 25, 2022

First Submission Date that Met QC Criteria

Jan 25, 2022

First Posted Date

Feb 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2022

Last Update Posted Date

Feb 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mhamed Sami Mebazaa, Professor head of anesthesia and intensive care department, Mongi Slim HospitalPrincipal Investigator

Lead Sponsor

Mongi Slim HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Melatonin 5 MG Sublingual Tablet	Drug	Melatonin 5 mg 12 hours and 2 hours prior to surgery	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
preoperative anxiety	preoperative anxiety scale	1 hour before surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients scheduled for hip fracture surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mhamed Sami Mebazaa, Prof	Contact	0021622252589		msmebazaa@gmail.com
Asma Ben Souissi, Assoc Prof	Contact	0021698336883		bsouissiasma@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin
D000286	Administration, Sublingual
D006919	Hydroxyzine

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided