The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03208452

Enrollment

Registered

2017-07-05

Start date

2017-03-19

Completion date

2018-12-19

Last updated

2023-09-11

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

Conditions

Agitation,Psychomotor

Brief summary

This study designed to evaluate the correlation between the effect of intraoperative magnesium sulfate infusion and the incidence of emergence agitation after pediatric ophthalmic surgery

Detailed description

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.

Interventions

DRUGMagnesium Sulfate

Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation

DRUGNormal saline

Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 7 Years

Healthy volunteers

Yes

Inclusion criteria

* pediatric patients who are planned to operate ophthalmic surgery under general anesthesia aged 4-7 years

Exclusion criteria

* ASA class ≥ III * imbalance of electrolyte * myocardial damage or conduction abnormality on ECG * myasthenia gravis or any other neuromuscular disease * impaired renal function * denial to participate in study or not be able to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
the incidence of emergence agitation (EA)	15 minute interval at the post-anesthetic care unit (PACU)	Using PAED (pediatric anesthesia emergence delirium) score, consider the score 10 or more as occuring of EA. Comparing the score between the placebo group and the intervention group for the difference of the incidence of EA.

Secondary

Measure	Time frame	Description
the severity of EA	15 minute interval at the post-anesthetic care unit (PACU)	Comparing the maximal PAED score between the placebo group and the intervention group for evaluating difference of severity of EA.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026