AnesthesiaNCT06031961
The Premedication Properties of Oral Melatonin in Pediatrics Undergoing Therapeutic Cardiac Catheterization
A study testing melatonin in people with Anesthesia, run by Al-Azhar University at 1 site in Iraq.
Trial summary
The evaluation of oral melatonin efficacy as premedicant agent in pediatrics undergoing elective cardiac interventions is the primary outcomes of our trail. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 10 Sep 2023to 15 Aug 2024
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 4-12 years.
- scheduled for elective therapeutic cardiac catheterization
- ASA I and II
Who cannot join
- ASA III or more than.
- Drug allergy.
- Any of contraindication for general anesthesia.
- Mental and neurological diseases.
- disapproval or dissatisfaction
- Liver disease
Show all 10Show fewer
- Diabetic children
- Thyroid storm
- Sleep disorders
- Intake of antipsychotics.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Ministry of Health
Baghdad, Thi-Qar, 00964
Abd-Alrahman Al-Batat, +9647830921522, Thiqarhealth@gmail.com
About this study
Official title: A Double-blind Randomized Placebo - Controlled Trial of Oral Melatonin as Premedication Agent in Pediatrics Undergoing Therapeutic Cardiac Catheterization
The evaluation of oral melatonin efficacy as premedicant agent in pediatrics undergoing elective cardiac interventions is the primary outcomes of our trail.
Read the detailed description
About 65 % of children whom undergoing surgery and anesthesia are suffering from keen anxiety and stress especially in the preoperative holding area. This situation mostly extends to the parents and this can worse the child response before surgery. The intensity of child anxiety had been reported to be a powerful predictor for incidence of hallucination in the recovery period and new-onset unpleasant behavioral changes such as nightmares and enuresis. In general, patients' preoperative anxiety if not controlled or reduced by premeditations, it can influence the surgical outcomes such as the postoperative pain, analgesic requirements, length of hospitality. Many of systemic physiological changes may be associated with the anxiety; such as elevated respiratory rate, elevated blood pressure, increased the heart rate and developing the risky of arrhythmia; all of these can be dilemmas and obstacles in the way of the anesthesiologist in choosing the appropriate method of anesthesia or the appropriate drugs for the starting and continuation of anesthesia. At the beginning of the eighties of the last century, the midazolam had been presented as the finest oral premedication agent which used in the pre-operative period for children to reduce the anxiety, and its quickly achieved wide acceptance as the preferred primer before induction of anesthesia. Rapid absorption during oral administration, multiple route administration and low incidence of nausea with its use when compared with other benzodiazepines, all these features helped to favor the midazolam for pre-operative use as a premedication in pediatrics. Despite the decent advantages that midazolam has in use before surgical interventions as a premedication agent, especially for children, it has some drawbacks that may affect the results of the surgical procedure and the anesthesia plan. Paradoxical reactions, interaction with opioids, overdue evacuation during the recovery time and capricious bioavailability are the most common drawbacks of midazolam in general. Some of these effects of midazolam had been shown to vary with patient age. In the presence of such drawbacks with the use of midazolam, the emergence of a suitable alternative may be widely accepted. Naturally, the N-acetyl-5-methoxy-tryptamine, which is also known as the Melatonin, is a biogenic amine which is firstly discovered in the middle of last century (1958) by Aaron B. Lerner in Yale University. After a while, the melatonin had been reported to be synthesized in animals, plants and even in unicellular organisms such as bacteria. In humans, the melatonin is mainly produced by the bovine pineal glands which is a small pine-cone shaped structure and located on the roof of the 3rd ventricle, deeply within the brain. In addition to production of melatonin; the main function of pineal gland; the gland also secrets some substances such as Oxytocin, Serotonin and Orexin in responding to influencing by neurotransmitters from neurons and nerve cells. The lymphocytes, bone marrow, eyes, and the gastrointestinal tract had been recently documented to a site production of melatonin hormone in human body.
Sleep cycle, mood, memory dreaming, immune activity, learning fertility and reproduction are the common physiological activities which regulated mainly by the melatonin in humans, all of these functions are accomplished through direct stimulation or binding to melatonin receptors.
European Medicines Agency had licensed the synthetic melatonin in form of tablets (2 mg) and (3 mg) in United Kingdom (UK) and Hungary. Also there is a licensed oral solution of 1mg/ml. The unlicensed synthetic melatonin is available in different forms from Kidmel® \& Kidnaps®, Special Products Limited in the UK in liquid formulations and capsule formulation of 2 \& 3 mg.
Many qualities of the chemical melatonin, which is mostly produced by the pineal gland, may help explain why it has cardio protective benefits. Melatonin may have receptor-mediated or receptor-independent protective effects. Ischemia/reperfusion (IR) injury has been shown to affect many organs, including the heart, liver, kidney, gut, testis, brain, and lung. Melatonin has been shown to offer numerous protective advantages. Melatonin's potent antioxidant qualities, as well as its capacity to encourage the synthesis of other antioxidants such as glutathione reductase, catalase, glutathione peroxidase, and superoxide dismutase, all contribute to its protective effects.
As a result, it acts as both an indirect antioxidant and a free radical scavenger. Because melatonin receptors are found in the vasculature, it is possible that melatonin has local control over cardiovascular diseases. Furthermore, the amount of melatonin generated by persons suffering from coronary artery disease is inversely connected to the stage of the disease-the less melatonin produced, the more advanced the disease.
- Conditions
- Anesthesia
- Being tested
- melatonin
- Keywords
- Melatonin, premedication, preoperative anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
Also called Placebo
We will premedicate the children whom involved in the 1st group with 0.5 mg/kg oral melatonin in the midnight before surgery and the dose will be repeated at morning before getting in the catheterization room
| Study group | Role | What they receive |
|---|---|---|
| 1st group: Melatonin group | Active comparator | All children in this group have to receive 0.5 mg/kg of melatonin(maximum dose 20 mg) which will be administered orally on the night before surgery ( at 12 am) and immediately before 30 minutes before entering the catheterization room. Receives: Drug: melatonin |
| 2nd group: Placebo group | Placebo comparator | All children in this group have to receive a placebo which will be administered orally on the night before surgery and immediately before 30 minutes before entering the catheterization room. Receives: Drug: melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative anxiety
Modified Yale Preoperative Anxiety Scale (mYPAS)
Measured: 30 minutes before 2nd dose of premedication, 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.
Secondary outcomes (1)
Sedation level
The University of Michigan Sedation Scale (UMSS)
Measured: 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start10 Sep 2023 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Ali, Al-Azhar University
- Investigators
- Mohamed kahloul, professor, Study chair, souse university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031961
- Sponsor's protocol ID
- Melatonin in PA
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2023
- Last updated
- 11 Sep 2023
- 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo - Controlled Trial of Oral Melatonin as Premedication Agent in Pediatrics Undergoing Therapeutic Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT06031961
- Acronym / sponsor ID
- Melatonin in PA
- Conditions
- Anesthesia
- Keywords
- Melatonin, premedication, preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 11 Sep 2023 (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.
The evaluation of oral melatonin efficacy as premedicant agent in pediatrics undergoing elective cardiac interventions is the primary outcomes of our trail.
Detailed description
About 65 % of children whom undergoing surgery and anesthesia are suffering from keen anxiety and stress especially in the preoperative holding area. This situation mostly extends to the parents and this can worse the child response before surgery. The intensity of child anxiety had been reported to be a powerful predictor for incidence of hallucination in the recovery period and new-onset unpleasant behavioral changes such as nightmares and enuresis. In general, patients' preoperative anxiety if not controlled or reduced by premeditations, it can influence the surgical outcomes such as the postoperative pain, analgesic requirements, length of hospitality. Many of systemic physiological changes may be associated with the anxiety; such as elevated respiratory rate, elevated blood pressure, increased the heart rate and developing the risky of arrhythmia; all of these can be dilemmas and obstacles in the way of the anesthesiologist in choosing the appropriate method of anesthesia or the appropriate drugs for the starting and continuation of anesthesia. At the beginning of the eighties of the last century, the midazolam had been presented as the finest oral premedication agent which used in the pre-operative period for children to reduce the anxiety, and its quickly achieved wide acceptance as the preferred primer before induction of anesthesia. Rapid absorption during oral administration, multiple route administration and low incidence of nausea with its use when compared with other benzodiazepines, all these features helped to favor the midazolam for pre-operative use as a premedication in pediatrics. Despite the decent advantages that midazolam has in use before surgical interventions as a premedication agent, especially for children, it has some drawbacks that may affect the results of the surgical procedure and the anesthesia plan. Paradoxical reactions, interaction with opioids, overdue evacuation during the recovery time and capricious bioavailability are the most common drawbacks of midazolam in general. Some of these effects of midazolam had been shown to vary with patient age. In the presence of such drawbacks with the use of midazolam, the emergence of a suitable alternative may be widely accepted. Naturally, the N-acetyl-5-methoxy-tryptamine, which is also known as the Melatonin, is a biogenic amine which is firstly discovered in the middle of last century (1958) by Aaron B. Lerner in Yale University. After a while, the melatonin had been reported to be synthesized in animals, plants and even in unicellular organisms such as bacteria. In humans, the melatonin is mainly produced by the bovine pineal glands which is a small pine-cone shaped structure and located on the roof of the 3rd ventricle, deeply within the brain. In addition to production of melatonin; the main function of pineal gland; the gland also secrets some substances such as Oxytocin, Serotonin and Orexin in responding to influencing by neurotransmitters from neurons and nerve cells. The lymphocytes, bone marrow, eyes, and the gastrointestinal tract had been recently documented to a site production of melatonin hormone in human body.
Sleep cycle, mood, memory dreaming, immune activity, learning fertility and reproduction are the common physiological activities which regulated mainly by the melatonin in humans, all of these functions are accomplished through direct stimulation or binding to melatonin receptors.
European Medicines Agency had licensed the synthetic melatonin in form of tablets (2 mg) and (3 mg) in United Kingdom (UK) and Hungary. Also there is a licensed oral solution of 1mg/ml. The unlicensed synthetic melatonin is available in different forms from Kidmel® \& Kidnaps®, Special Products Limited in the UK in liquid formulations and capsule formulation of 2 \& 3 mg.
Many qualities of the chemical melatonin, which is mostly produced by the pineal gland, may help explain why it has cardio protective benefits. Melatonin may have receptor-mediated or receptor-independent protective effects. Ischemia/reperfusion (IR) injury has been shown to affect many organs, including the heart, liver, kidney, gut, testis, brain, and lung. Melatonin has been shown to offer numerous protective advantages. Melatonin's potent antioxidant qualities, as well as its capacity to encourage the synthesis of other antioxidants such as glutathione reductase, catalase, glutathione peroxidase, and superoxide dismutase, all contribute to its protective effects.
As a result, it acts as both an indirect antioxidant and a free radical scavenger. Because melatonin receptors are found in the vasculature, it is possible that melatonin has local control over cardiovascular diseases. Furthermore, the amount of melatonin generated by persons suffering from coronary artery disease is inversely connected to the stage of the disease-the less melatonin produced, the more advanced the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st group: Melatonin group | Active comparator | Drug: melatoninAll children in this group have to receive 0.5 mg/kg of melatonin(maximum dose 20 mg) which will be administered orally on the night before surgery ( at 12 am) and immediately before 30 minutes before entering the catheterization room. |
| 2nd group: Placebo group | Placebo comparator | Drug: melatoninAll children in this group have to receive a placebo which will be administered orally on the night before surgery and immediately before 30 minutes before entering the catheterization room. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 4-12 years.
- scheduled for elective therapeutic cardiac catheterization
- ASA I and II
Key exclusion criteria (10 listed)
- ASA III or more than.
- Drug allergy.
- Any of contraindication for general anesthesia.
- Mental and neurological diseases.
- disapproval or dissatisfaction
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 |
|---|---|---|
| melatoninAlso: PlaceboWe will premedicate the children whom involved in the 1st group with 0.5 mg/kg oral melatonin in the midnight before surgery and the dose will be repeated at morning before getting in the catheterization room | Drug | 1st group: Melatonin group, 2nd group: Placebo group |
Primary outcome
preoperative anxiety
Time frame: 30 minutes before 2nd dose of premedication, 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.
Modified Yale Preoperative Anxiety Scale (mYPAS)
1 secondary outcome
Sedation level
Time frame: 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 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.
Mohamed kahloul, professor study chair
souse university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin in people with Anesthesia, run by Al-Azhar University at 1 site in Iraq.
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 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: status not confirmed, as of the sponsor's last update on 11 Sep 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 Iraq. 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.
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 Hussein Hussein (009647811593388, hussein.hussein@alayen.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative anxiety (time frame: 30 minutes before 2nd dose of premedication, 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.). 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 11 Sep 2023.