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

Phase 4

Completed

• Conditions: Agitation,Psychomotor
• Interventions: Drug: Normal saline; Drug: Magnesium Sulfate

• Registration Number: NCT03208452
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2017-03-19
• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Primary Completion: 2018-12-19
• Study Completion: 2018-12-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline(NS) group	Normal saline	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
Magnesium group	Magnesium Sulfate	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of