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The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children

The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03132701
Enrollment
66
Registered
2017-04-28
Start date
2017-06-08
Completion date
2017-12-12
Last updated
2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Brief summary

Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children

Detailed description

Children \< 8 years old who scheduled for elective opthalmic surgery are randomly assigned to Magnesium (Mg) group and control group. Before anesthetic induction, modified Yale Preoperative Anxiety Scale (m-YPAS) is assessed. Routine anesthetic induction is performed, and neuromuscular blocker is not used. Laryngeal mask airway is inserted and controlled ventilation is started. In Mg group, Mg of 30 mg/kg is administered for 10 minutes and then continuously infused (10mg/kg/hr) until 5 minutes before surgery end. In control group, the similar volume of saline is infused. Pediatric Anesthesia Emergence Delirium (PAED) scale and pain score (Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) will be measured immediately after and 30 minutes after surgery.

Interventions

DRUGMagnesium

Mg is administered during anesthesia until 5 minutes before surgery ends

DRUGSaline

Same volume of saline is infused until 5 minutes before surgery ends

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
Yes

Inclusion criteria

* Children aged between 2 and 7 years * American Society of Anesthesiologist physical status 1 and 2 * Children scheduled for opthalmic surgery

Exclusion criteria

* Allergy history to any drugs * Risk of malignant hyperthermia * Neuromuscular disease * With arrhythmia * Any pulmonary, cardiac, hepatic and renal disease * Obesity

Design outcomes

Primary

MeasureTime frameDescription
Emergence delirium30 minutes after anesthesiaPediatric Anesthesia Emergence Delirium (PAED) scale

Secondary

MeasureTime frameDescription
Pain scoreAt each two points: during emergence in operating room and 30 minutes after surgery endsModified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS)
NauseaAt each two points: during emergence in operating room and 30 minutes after surgery endsvisual analogue scale
vomitingAt each two points: during emergence in operating room and 30 minutes after surgery endsnumber
Duration of post-anesthetic care unit (PACU) stayDuring 1 hour after surgery at PACUDuration of post-anesthetic care unit (PACU) stay

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026