Emergence AgitationPhase 4NCT05223010
Melatonin for Pediatric Emergence Agitation
A Phase 4 study testing Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg, Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg and Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg in people with Emergence Agitation, run by Menoufia University at 1 site in Egypt.
Trial summary
efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg, Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg and Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2022to 3 Dec 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I
- scheduled for unilateral inguinal herniorrhaphy
- parents conscent
Who cannot join
- allergy to this study drug
- Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction
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: Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics
efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries
Read the detailed description
Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.
Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects
- Conditions
- Emergence Agitation
- Being tested
- Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg, Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg, Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg, Sevoflurane
- Keywords
- melatonin, emergence agitation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kgDrug
will be administered 1 hour before arrival to operating room
Melatonin 5 MG/15 ML Oral Solution 0.2mg/kgDrug
will be administered 1 hour before arrival to operating room
Melatonin 5 MG/15 ML Oral Solution 0.4mg/kgDrug
will be administered 1 hour before arrival to operating room
SevofluraneDrug
for anaesthesia induction 3-8 MAC
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 39 participant will receive melatonin 0.05 mg/kg Receives: Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg; Drug: Sevoflurane |
| 2 | Active comparator | 39 participant will receive melatonin 0.2 mg/kg Receives: Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg; Drug: Sevoflurane |
| 3 | Active comparator | 39 participant will receive melatonin 0.4 mg/kg Receives: Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
emergence behaviour
change from baseline on a 5 point scale
Measured: 5 min, 15 min and 30 min after arrival to recovery
Secondary outcomes (1)
yale preoperative anxiety scale
3 domain scale
Measured: before administration of oral premedication and before anaesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start30 Jan 2022
- Primary completion2 Jun 2022
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 117 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
- NCT05223010
- Sponsor's protocol ID
- 1/2022ANET3-A
- Status last verified
- Oct 2023
- First submitted
- 7 Jan 2022
- Last updated
- 12 Oct 2023
- 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics
- ClinicalTrials.gov ID
- NCT05223010
- Acronym / sponsor ID
- 1/2022ANET3-A
- Conditions
- Emergence Agitation
- Keywords
- melatonin, emergence agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 3 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.
efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries
Detailed description
Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.
Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg, Drug: Sevoflurane39 participant will receive melatonin 0.05 mg/kg |
| 2 | Active comparator | Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg, Drug: Sevoflurane39 participant will receive melatonin 0.2 mg/kg |
| 3 | Active comparator | Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg, Drug: Sevoflurane39 participant will receive melatonin 0.4 mg/kg |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I
- scheduled for unilateral inguinal herniorrhaphy
- parents conscent
Key exclusion criteria (2 listed)
- allergy to this study drug
- Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction
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/15 ML Oral Solution 0.05 mg/kgwill be administered 1 hour before arrival to operating room | Drug | 1 |
| Melatonin 5 MG/15 ML Oral Solution 0.2mg/kgwill be administered 1 hour before arrival to operating room | Drug | 2 |
| Melatonin 5 MG/15 ML Oral Solution 0.4mg/kgwill be administered 1 hour before arrival to operating room | Drug | 3 |
| Sevofluranefor anaesthesia induction 3-8 MAC | Drug | 1, 2, 3 |
Primary outcome
emergence behaviour
Time frame: 5 min, 15 min and 30 min after arrival to recovery
change from baseline on a 5 point scale
1 secondary outcome
yale preoperative anxiety scale
Time frame: before administration of oral premedication and before anaesthesia induction
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 12 Oct 2023.
- 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 5 MG/15 ML Oral Solution 0.05 mg/kg, Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg and Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg in people with Emergence Agitation, 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 3 inclusion and 2 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 12 Oct 2023. 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?
emergence behaviour (time frame: 5 min, 15 min and 30 min after arrival to recovery). 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 12 Oct 2023.