MagnesiumPhase 2/3NCT07655817
Oral Versus Intravenous Magnesium on Emergence Delirium
A Phase 2/3 study testing Magnesium glycinate, Magnesium sulfate injection and Oral juice and intravenous saline in people with Magnesium and Emergence Delirium, run by Tanta University at 1 site in Egypt.
Trial summary
This prospective randomized controlled study will be conducted to compare the effects of preoperative oral magnesium and intraoperative IV magnesium on the incidence and severity of emergence delirium in children undergoing adenotonsillectomy using sevoflurane anesthesia. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Magnesium, Emergence Delirium, Children
- What is being tested?
- Magnesium glycinate, Magnesium sulfate injection and Oral juice and intravenous saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 25 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 7 years
- American Society of Anesthesiologist (ASA) Status I or II
- Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.
Who cannot join
- Parents declined to participate in the trial
- Behavioral changes, neurological or psychiatric problems
- Anticonvulsant or sedative drugs
- Physical or developmental abnormalities
- Allergies to magnesium
- cardiovascular, renal, bone, or gastrointestinal diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbia Governorate, 31527
Osama M Rehab, MD, +201095210806 ext. 002, osamarehab@med.tanta.edu.eg
About this study
Official title: Effect of Oral Versus Intravenous Magnesium on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Two-Center, Randomized, Double-Blind, Placebo-Controlled Study
This prospective randomized controlled study will be conducted to compare the effects of preoperative oral magnesium and intraoperative IV magnesium on the incidence and severity of emergence delirium in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Read the detailed description
Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness.
Regarding its use as a preventive measure against emergence delirium in children, only intraoperative IV route was studied and the results of previous reports were inconsistent.
Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value.
In this novel study, we will compare the use of magnesium via two different routes, either oral route before surgery or IV route after sevoflurane induction, regarding their preventive value against the occurrence of emergence delirium in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence delirium, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may suggest a prophylactic benefit against emergence delirium. So, we hypothesize that either oral or IV magnesium therapy may decrease the incidence of emergence delirium in this setting.
- Conditions
- Magnesium, Emergence Delirium, Children, Adenotonsillectomy
- Being tested
- Magnesium glycinate, Magnesium sulfate injection, Oral juice and intravenous saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium glycinateDrug
cases will receive preoperative oral magnesium dose of 150 mg (10 ml of Magnesium Glycinate Liquid Trace syrup) at two hours before surgery, and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
Magnesium sulfate injectionDrug
cases will receive oral lemon juice (10 ml) at two hours before surgery, and will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
Oral juice and intravenous salineOther
cases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Oral magnesium group | Experimental | cases will receive preoperative oral magnesium dose of 150 mg at two hours before surgery. Receives: Drug: Magnesium glycinate |
| Intravenous magnesium group | Experimental | cases will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure. Receives: Drug: Magnesium sulfate injection |
| Control group | Placebo comparator | cases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure. Receives: Other: Oral juice and intravenous saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence delirium
Pediatric Anesthesia Emergence Delirium scale will be used and a score >12 together with a Delirium-specific score ≥ 9 will be considered a diagnostic endpoint for the development of delirium. it will be assessed on arrival to the post-anesthesia care unit and every 15 min thereafter for 1 hour
Measured: Up to 1 hour after surgery.
Secondary outcomes (9)
Severity of emergence delirium
Pediatric Anesthesia Emergence Delirium scale scores will be recorded
Measured: Up to 1 hour after surgery.
Postoperative pain
the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at post-anesthesia care unit arrival and every 0.25 hour for 1 hour after surgery. A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl
Measured: Up to 1 hour after surgery.
Parental separation anxiety
It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured, but not clinging to parents; and 4 signifies crying and clinging to parents. A score of 1 or 2 was considered as 'acceptable' separation
Measured: Perioperative
Mask acceptance
The ease of mask acceptance will be graded using the Mask Acceptance Score at the time of induction of general anesthesia with sevoflurane. It is a 4-point scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A score of 1 or 2 was considered 'satisfactory' mask acceptance.
Measured: Perioperative
The total dose of rescue propofol
Parental contact will be initiated as the first line management of delirium. If the PAED score remains at least 13 with a Delirium-specific score at least 9 despite parental contact, 1 mg/kg IV propofol will be administered. This dose will be repeated after 15 min if the child still agitated. The total dose of rescue propofol will be recorded.
Measured: Up to 1 hour after surgery.
The total dose of rescue fentanyl
A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl. This dose will be repeated after 15 min if the child still in pain. The total dose of rescue fentanyl will be recorded
Measured: Up to 1 hour after surgery.
Extubation time
At the end of surgery, the trachea will be extubated with the patient in the lateral position after confirmation that the gag reflex returned
Measured: End of surgery.
Negative behavior changes
Post Hospitalization Behavior Questionnaire will be used to evaluate the child's baseline behavior before anesthesia and any negative behavioral changes at 24 hours postoperatively. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the Post Hospitalization Behavior Questionnaire items in comparison with the pre-anesthesia baseline values.
Measured: 24 hours after surgery.
Side effects
Postoperative nausea and vomiting , hypotension, bradycardia will be recorded
Measured: Up to 1 hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026
- Primary completion24 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MagnesiumStudies of the same condition, open and under way.
- More trials run by Tanta 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655817
- Sponsor's protocol ID
- 36265PR76/5/26
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Versus Intravenous Magnesium on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Two-Center, Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07655817
- Acronym / sponsor ID
- 36265PR76/5/26
- Conditions
- Magnesium, Emergence Delirium, Children, Adenotonsillectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 18 Jun 2026 (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.
This prospective randomized controlled study will be conducted to compare the effects of preoperative oral magnesium and intraoperative IV magnesium on the incidence and severity of emergence delirium in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Detailed description
Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness.
Regarding its use as a preventive measure against emergence delirium in children, only intraoperative IV route was studied and the results of previous reports were inconsistent.
Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value.
In this novel study, we will compare the use of magnesium via two different routes, either oral route before surgery or IV route after sevoflurane induction, regarding their preventive value against the occurrence of emergence delirium in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence delirium, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may suggest a prophylactic benefit against emergence delirium. So, we hypothesize that either oral or IV magnesium therapy may decrease the incidence of emergence delirium in this setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Oral magnesium group | Experimental | Drug: Magnesium glycinatecases will receive preoperative oral magnesium dose of 150 mg at two hours before surgery. |
| Intravenous magnesium group | Experimental | Drug: Magnesium sulfate injectioncases will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure. |
| Control group | Placebo comparator | Other: Oral juice and intravenous salinecases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 4 to 7 years
- American Society of Anesthesiologist (ASA) Status I or II
- Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.
Key exclusion criteria (6 listed)
- Parents declined to participate in the trial
- Behavioral changes, neurological or psychiatric problems
- Anticonvulsant or sedative drugs
- Physical or developmental abnormalities
- Allergies to magnesium
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 |
|---|---|---|
| Magnesium glycinatecases will receive preoperative oral magnesium dose of 150 mg (10 ml of Magnesium Glycinate Liquid Trace syrup) at two hours before surgery, and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure. | Drug | Oral magnesium group |
| Magnesium sulfate injectioncases will receive oral lemon juice (10 ml) at two hours before surgery, and will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure. | Drug | Intravenous magnesium group |
| Oral juice and intravenous salinecases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure. | Other | Control group |
Primary outcome
Incidence of emergence delirium
Time frame: Up to 1 hour after surgery.
Pediatric Anesthesia Emergence Delirium scale will be used and a score >12 together with a Delirium-specific score ≥ 9 will be considered a diagnostic endpoint for the development of delirium. it will be assessed on arrival to the post-anesthesia care unit and every 15 min thereafter for 1 hour
9 secondary outcomes
Severity of emergence delirium
Time frame: Up to 1 hour after surgery.
Postoperative pain
Time frame: Up to 1 hour after surgery.
Parental separation anxiety
Time frame: Perioperative
Mask acceptance
Time frame: Perioperative
The total dose of rescue propofol
Time frame: Up to 1 hour after surgery.
The total dose of rescue fentanyl
Time frame: Up to 1 hour after surgery.
Extubation time
Time frame: End of surgery.
Negative behavior changes
Time frame: 24 hours after surgery.
Side effects
Time frame: Up to 1 hour after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium glycinate, Magnesium sulfate injection and Oral juice and intravenous saline in people with Magnesium and Emergence Delirium, run by Tanta 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 6 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama M Rehab, MD (+201095210806 ext. 002, osamarehab@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence delirium (time frame: Up to 1 hour after 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 6 Jul 2026.