Completed

The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation After Pediatric Ophthalmic Surgery

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What is being tested

Magnesium Sulfate

+ Normal saline

Drug
Who is being recruted

Aberrant Motor Behavior in Dementia+8

+ Behavior

+ Behavioral Symptoms

From 4 to 7 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 4
Interventional
Study Start: March 2017
See protocol details

Summary

Principal SponsorSeoul National University Bundang Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 19, 2017

Actual date on which the first participant was enrolled.

Emergence agitation (EA) is a frequent postoperative complication in pediatric patients after general anesthesia. There are several suggested causes of EA and pain has been considered one of them. Magnesium is an N-methyl-D-aspartate (NMDA) receptor antagonist and increasingly used as an analgesic-adjuvant. We evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether the intraoperative infusion of magnesium sulfate reduces the incidence of EA in pediatric patients who undergo ophthalmic outpatient surgery.

Official TitleThe Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation After Pediatric Ophthalmic Surgery
NCT03208452
Principal SponsorSeoul National University Bundang Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

92 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 7 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aberrant Motor Behavior in DementiaBehaviorBehavioral SymptomsNervous System DiseasesNeurologic ManifestationsPsychomotor AgitationPsychomotor DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsDyskinesias

Criteria

1 inclusion criteria required to participate
pediatric patients who are planned to operate ophthalmic surgery under general anesthesia aged 4-7 years
6 exclusion criteria prevent from participating
ASA class ≥ III
imbalance of electrolyte
myocardial damage or conduction abnormality on ECG
myasthenia gravis or any other neuromuscular disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
loading dose of 50mg/kg magnesium sulfate during 10minutes before starting of surgery, during the surgery, continuous infusion of magnesium sulfate by 15mg/kg/h

Group II

Placebo
loading 50mL of normal saline during 10minutes before starting of surgery, after starting of surgery, continuous infusion of normal saline as placebo by 0.15mg/kg/h until the end of surgery

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Seoul National University Bundang Hospital

Seongnam-si, South KoreaOpen Seoul National University Bundang Hospital in Google Maps
CompletedOne Study Center