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Clinical Trials/NCT03208452
NCT03208452
Completed
Phase 4

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

Seoul National University Bundang Hospital1 site in 1 country92 target enrollmentMarch 19, 2017

Overview

Phase
Phase 4
Intervention
Normal saline
Conditions
Agitation,Psychomotor
Sponsor
Seoul National University Bundang Hospital
Enrollment
92
Locations
1
Primary Endpoint
the incidence of emergence agitation (EA)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 19, 2017
End Date
December 19, 2018
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LEE YEA JI

clinical professor

Seoul National University Bundang Hospital

Eligibility Criteria

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

Arms & Interventions

Normal saline(NS) group

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

Intervention: Normal saline

Magnesium group

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

Intervention: Magnesium Sulfate

Outcomes

Primary Outcomes

the incidence of emergence agitation (EA)

Time Frame: 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 Outcomes

  • the severity of EA(15 minute interval at the post-anesthetic care unit (PACU))

Study Sites (1)

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