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Completed

NCT Number: NCT03208452

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

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

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Key information

Conditions

Agitation,Psychomotor Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

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

Other names: 10% magnesium sulfate

normal saline

Drug

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

Other names: 0.9% isotonic normal saline

Primary outcomes

  1. 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

  1. the severity of EA

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2017
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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