Preoperative AnxietyNCT05224167
Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
A study testing Melatonin 5 MG Sublingual Tablet and Hydroxyzine in people with Preoperative Anxiety, run by Mongi Slim Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Melatonin 5 MG Sublingual Tablet and Hydroxyzine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients scheduled for hip fracture surgery
Who cannot join
- Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Preoperative Anxiety
- Being tested
- Melatonin 5 MG Sublingual Tablet, Hydroxyzine
- Keywords
- Melatonin, Hydroxizin, Hip fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 5 MG Sublingual TabletDrug
Melatonin 5 mg 12 hours and 2 hours prior to surgery
HydroxyzineDrug
Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery Receives: 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 Receives: Drug: Hydroxyzine |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative anxiety
preoperative anxiety scale
Measured: 1 hour before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224167
- Sponsor's protocol ID
- Melatonin versus Hydroxizin
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT05224167
- Acronym / sponsor ID
- Melatonin versus Hydroxizin
- Conditions
- Preoperative Anxiety
- Keywords
- Melatonin, Hydroxizin, Hip fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Melatonin 5 MG Sublingual Tabletpatients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery |
| Group B | Active comparator | Drug: Hydroxyzinepatients of this group will receive 1 mg/kg of Hydroxizin 12 hours and 1 mg/ kg 2 hours prior to surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients scheduled for hip fracture surgery
Key exclusion criteria (1 listed)
- Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 5 MG Sublingual TabletMelatonin 5 mg 12 hours and 2 hours prior to surgery | Drug | Group A |
| HydroxyzineHydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery | Drug | Group B |
Primary outcome
preoperative anxiety
Time frame: 1 hour before surgery
preoperative anxiety scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 5 MG Sublingual Tablet and Hydroxyzine in people with Preoperative Anxiety, run by Mongi Slim Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mhamed Sami Mebazaa, Prof (0021622252589, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative anxiety (time frame: 1 hour before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.