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Oral Versus Intravenous Magnesium on Emergence Delirium

ConditionsMagnesiumEmergence DeliriumChildrenAdenotonsillectomy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age4-7
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 4 to 7 years

American Society of Anesthesiologist (ASA) Status I or II

Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.

Disqualifiers

Parents declined to participate in the trial

Behavioral changes, neurological or psychiatric problems

Anticonvulsant or sedative drugs

Physical or developmental abnormalities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnesium glycinate

    Drug

    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 injection

    Drug

    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 saline

    Other intervention

    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.

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: Oral magnesium groupExperimental treatment 1 intervention
Group B: Intravenous magnesium groupExperimental treatment 1 intervention
Group C: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 1 hour after surgery.

Secondary outcomes

1

Severity of emergence delirium

Pediatric Anesthesia Emergence Delirium scale scores will be recorded

Time frame
Up to 1 hour after surgery.
2

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

Time frame
Up to 1 hour after surgery.
3

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

Time frame
Perioperative
4

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.

Time frame
Perioperative

Other outcomes

Sponsors and contacts

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Tanta University

Lead sponsor

Source ClinicalTrials.gov
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