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

Agitation,Psychomotor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208452
• Other study ID #: B1605/346-002
• Status: Completed
• Phase: Phase 4
• Start date: March 19, 2017
• Est. completion date: December 19, 2018

Study information

• Verified date: September 2023
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Magnesium Sulfate
Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation
• Normal saline
Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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