Oral Versus Intravenous Magnesium on Emergence Delirium
1 juli 2026 uppdaterad av: Osama Rehab, Tanta University
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
360
Fas
- Fas 2
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Osama M Rehab, MD
- Telefonnummer: 002 +201095210806
- E-post: osamarehab@med.tanta.edu.eg
Studieorter
-
-
Gharbia Governorate
-
Tanta, Gharbia Governorate, Egypten, 31527
- Rekrytering
- Tanta University Hospitals
-
Kontakt:
- Osama M Rehab, MD
- Telefonnummer: 002 +201095210806
- E-post: osamarehab@med.tanta.edu.eg
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Children aged 4 to 7 years
- American Society of Anesthesiologist (ASA) Status I or II
- Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.
Exclusion Criteria:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Oral magnesium group
cases will receive preoperative oral magnesium dose of 150 mg at two hours before surgery.
|
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.
|
|
Experimentell: Intravenous magnesium group
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.
|
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.
|
|
Placebo-jämförare: Control group
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of emergence delirium
Tidsram: 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
|
Up to 1 hour after surgery.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Severity of emergence delirium
Tidsram: Up to 1 hour after surgery.
|
Pediatric Anesthesia Emergence Delirium scale scores will be recorded
|
Up to 1 hour after surgery.
|
|
Postoperative pain
Tidsram: Up to 1 hour after surgery.
|
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
|
Up to 1 hour after surgery.
|
|
Parental separation anxiety
Tidsram: Perioperative
|
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
|
Perioperative
|
|
Mask acceptance
Tidsram: Perioperative
|
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.
|
Perioperative
|
|
The total dose of rescue propofol
Tidsram: Up to 1 hour after surgery.
|
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.
|
Up to 1 hour after surgery.
|
|
The total dose of rescue fentanyl
Tidsram: Up to 1 hour after surgery.
|
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
|
Up to 1 hour after surgery.
|
|
Extubation time
Tidsram: End of surgery.
|
At the end of surgery, the trachea will be extubated with the patient in the lateral position after confirmation that the gag reflex returned
|
End of surgery.
|
|
Negative behavior changes
Tidsram: 24 hours after surgery.
|
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.
|
24 hours after surgery.
|
|
Side effects
Tidsram: Up to 1 hour after surgery.
|
Postoperative nausea and vomiting , hypotension, bradycardia will be recorded
|
Up to 1 hour after surgery.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2026
Primärt slutförande (Beräknad)
24 december 2026
Avslutad studie (Beräknad)
25 december 2026
Studieregistreringsdatum
Först inskickad
13 juni 2026
Först inskickad som uppfyllde QC-kriterierna
13 juni 2026
Första postat (Faktisk)
18 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Mentala störningar
- Postoperativa komplikationer
- Patologiska processer
- Förvirring
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Delirium
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Emergence Delirium
- Svavelföreningar
- Oorganiska kemikalier
- Svavelsyror
- Sulfat
- Svavelsyror
- Magnesiumföreningar
- Magnesiumsulfat
- magnesiumdiglycinat
Andra studie-ID-nummer
- 36265PR76/5/26
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
The data will be available upon a reasonable request from the corresponding author.
Tidsram för IPD-delning
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Kriterier för IPD Sharing Access
The data will be available upon a reasonable request from the corresponding author.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .