AnxietyPhase 4NCT05221151
Melatonin vs Pregabalin for Anxiolysis and Sedation
A Phase 4 study testing Melatonin, Pregabalin and Ondansetron 4 MG in people with Anxiety, run by Menoufia University at 1 site in Egypt.
Trial summary
preoperative melatonin, pregabalin or both will be given to all patients preoperative Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Melatonin, Pregabalin and Ondansetron 4 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2022to 2 Oct 2022
- Phase
- Phase 4
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I or II
- patients undergoing hip arthroplasty
- patient consent for spinal anaesthesia
- patient alert, concious and good mental condition
Who cannot join
- Patients with any neurolgical or psychiatric history before the procedure
- Patients with a history of chronic pain
- patients with known allergy to any of this study drugs
- patients have Any contraindication to neuraxial block.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, University Hospitals
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Efficacy of Preoperative Melatonin Versus Pregabalin on Intraoperative Anxiolysis and Sedation During Hip Arthroplasty Under Regional Anesthesia
preoperative melatonin, pregabalin or both will be given to all patients preoperative
Read the detailed description
On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Sedation score (ramsay sedation score)(10) will be recorded on arrival to OR An 18-gauge cannula will be inserted in a peripheral vein and a warmed (37°C) lactated Ringer solution infusion was started. Ondansetron 4 mg will be administered intravenously as a prophylaxis against nausea and vomiting. Thereafter the patient will be supported in the sitting position. Intrathecal anaesthetic (room temperature hyperbaric bupivacaine 0.5% (20 mg) + fentanyl 25 μg (0.5 mL) will be given under complete aseptic technique . The patient was returned to the supine position for 15 min then to lateral position with operative side up.
HR and blood pressure will be measured every 2.5 minutes intraoperatively, however, the values will be recorded in the anesthesia chart only every five minutes for 2 hours then every 15 minutes for 3 hours. Durations will be calculated considering the time of spinal injection as time zero.
Hypotension (SAP<100 mmHg or <80% of the baseline measured before spinal anaesthesia) will be treated by ephedrine 6 mg, to be repeated if inadequate response within 2 minutes. If bradycardia (HR≤60 bpm) developed, atropine (0.6 mg) will be given to restore adequate HR (≥60 bpm).
- Conditions
- Anxiety
- Being tested
- Melatonin, Pregabalin, Ondansetron 4 MG
- Keywords
- melatonin, pregabalin
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
PregabalinDrug
In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery
Ondansetron 4 MGDrug
before spinal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| melatonin | Active comparator | 26 patients will receive melatonin 10 mg Receives: Drug: Melatonin; Drug: Ondansetron 4 MG |
| pregabalin | Active comparator | 26 patients will receive pregabalin 150 mg Receives: Drug: Pregabalin; Drug: Ondansetron 4 MG |
| melatonin and pregabalin | Active comparator | 26 patients will receive melatonin 5 mg plus pregabalin 75 mg Receives: Drug: Melatonin; Drug: Pregabalin; Drug: Ondansetron 4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
change of VAS of the patient on a scale from the night before surgery
Measured: on arrival to operating room then every 6 hours untill 48 hours
Ramsey Sedation scale
change of sedation of the patient on a scale from the night before surgery
Measured: on arrival to operating room then every 6 hours untill 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start30 Jan 2022
- Primary completion2 May 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221151
- Sponsor's protocol ID
- 1/2022ANET3-B
- Status last verified
- Dec 2022
- First submitted
- 7 Jan 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Melatonin Versus Pregabalin on Intraoperative Anxiolysis and Sedation During Hip Arthroplasty Under Regional Anesthesia
- ClinicalTrials.gov ID
- NCT05221151
- Acronym / sponsor ID
- 1/2022ANET3-B
- Conditions
- Anxiety
- Keywords
- melatonin, pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 2 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.
preoperative melatonin, pregabalin or both will be given to all patients preoperative
Detailed description
On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Sedation score (ramsay sedation score)(10) will be recorded on arrival to OR An 18-gauge cannula will be inserted in a peripheral vein and a warmed (37°C) lactated Ringer solution infusion was started. Ondansetron 4 mg will be administered intravenously as a prophylaxis against nausea and vomiting. Thereafter the patient will be supported in the sitting position. Intrathecal anaesthetic (room temperature hyperbaric bupivacaine 0.5% (20 mg) + fentanyl 25 μg (0.5 mL) will be given under complete aseptic technique . The patient was returned to the supine position for 15 min then to lateral position with operative side up.
HR and blood pressure will be measured every 2.5 minutes intraoperatively, however, the values will be recorded in the anesthesia chart only every five minutes for 2 hours then every 15 minutes for 3 hours. Durations will be calculated considering the time of spinal injection as time zero.
Hypotension (SAP<100 mmHg or <80% of the baseline measured before spinal anaesthesia) will be treated by ephedrine 6 mg, to be repeated if inadequate response within 2 minutes. If bradycardia (HR≤60 bpm) developed, atropine (0.6 mg) will be given to restore adequate HR (≥60 bpm).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| melatonin | Active comparator | Drug: Melatonin, Drug: Ondansetron 4 MG26 patients will receive melatonin 10 mg |
| pregabalin | Active comparator | Drug: Pregabalin, Drug: Ondansetron 4 MG26 patients will receive pregabalin 150 mg |
| melatonin and pregabalin | Active comparator | Drug: Melatonin, Drug: Pregabalin, Drug: Ondansetron 4 MG26 patients will receive melatonin 5 mg plus pregabalin 75 mg |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I or II
- patients undergoing hip arthroplasty
- patient consent for spinal anaesthesia
- patient alert, concious and good mental condition
Key exclusion criteria (4 listed)
- Patients with any neurolgical or psychiatric history before the procedure
- Patients with a history of chronic pain
- patients with known allergy to any of this study drugs
- patients have Any contraindication to neuraxial block.
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 |
|---|---|---|
| MelatoninIn the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery | Drug | melatonin, melatonin and pregabalin |
| PregabalinIn the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery | Drug | melatonin and pregabalin, pregabalin |
| Ondansetron 4 MGbefore spinal anaesthesia | Drug | melatonin, melatonin and pregabalin, pregabalin |
Primary outcome
VAS
Time frame: on arrival to operating room then every 6 hours untill 48 hours
change of VAS of the patient on a scale from the night before surgery
Ramsey Sedation scale
Time frame: on arrival to operating room then every 6 hours untill 48 hours
change of sedation of the patient on a scale from the night before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin, Pregabalin and Ondansetron 4 MG in people with Anxiety, run by Menoufia University at 1 site in Egypt.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: on arrival to operating room then every 6 hours untill 48 hours). The study lists 2 primary outcomes in all. 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 21 Dec 2022.