AgitationPhase 4NCT04908605
Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
A Phase 4 study testing Mirtazapine and Melatonin in people with Agitation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Agitation
- What is being tested?
- Mirtazapine and Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2021to 31 Mar 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II.
- Patients according to Mallampati classification I or II.
- Patients accepting the study and consenting.
- Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.
- Body mass index(BMI)<30
Who cannot join
- Patient's refusal.
- Known allergy to any of the study medications.
- History of obstructive sleep apnea.
- History of psychiatric illness or intake of antipsychotics.
- History of liver impairment.
- Pregnancy.
Show all 10Show fewer
- History of uncontrolled hypertension.
- History of renal disease.
- Body mass index (BMI) ≥30 kg/m2.
- Contraceptive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation.
Melatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults.
Mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Every patient will be given mirtazapine 30 mg tablet
MelatoninDrug
Every patient will be given melatonin 5 mg tablet
PlaceboDrug
Every patient will be given a matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine group (Group I) (n=55) | Active comparator | Not described Receives: Drug: Mirtazapine |
| Melatonin group (Group II) (n=55) | Active comparator | Not described Receives: Drug: Melatonin |
| Placebo group (Group III) (n=55) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of patients with the Riker sedation-agitation score ≥5
Total number of patients with the Riker sedation-agitation score ≥5
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start15 Jun 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908605
- Sponsor's protocol ID
- FMASU MS251 /202l
- Status last verified
- Apr 2022
- First submitted
- 27 May 2021
- Last updated
- 15 Apr 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
- ClinicalTrials.gov ID
- NCT04908605
- Acronym / sponsor ID
- FMASU MS251 /202l
- Conditions
- Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 1 Jun 2021 (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.
Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation.
Melatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults.
Mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine group (Group I) (n=55) | Active comparator | Drug: Mirtazapine |
| Melatonin group (Group II) (n=55) | Active comparator | Drug: Melatonin |
| Placebo group (Group III) (n=55) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II.
- Patients according to Mallampati classification I or II.
- Patients accepting the study and consenting.
- Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.
- Body mass index(BMI)<30
Key exclusion criteria (10 listed)
- Patient's refusal.
- Known allergy to any of the study medications.
- History of obstructive sleep apnea.
- History of psychiatric illness or intake of antipsychotics.
- History of liver impairment.
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 |
|---|---|---|
| MirtazapineEvery patient will be given mirtazapine 30 mg tablet | Drug | Mirtazapine group (Group I) (n=55) |
| MelatoninEvery patient will be given melatonin 5 mg tablet | Drug | Melatonin group (Group II) (n=55) |
| PlaceboEvery patient will be given a matching placebo tablet | Drug | Placebo group (Group III) (n=55) |
Primary outcome
Total number of patients with the Riker sedation-agitation score ≥5
Time frame: 24 hours postoperatively
Total number of patients with the Riker sedation-agitation score ≥5
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 15 Apr 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 Mirtazapine and Melatonin in people with Agitation, run by Ain Shams 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 5 inclusion and 10 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 15 Apr 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. Some participants in this study may receive a placebo. 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?
Total number of patients with the Riker sedation-agitation score ≥5 (time frame: 24 hours postoperatively). 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 15 Apr 2022.