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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03208452

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Agitation,Psychomotor	Drug: Magnesium Sulfate Drug: Normal saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 19, 2017

Actual Primary Completion Date :

Dec 19, 2018

Actual Study Completion Date :

Dec 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	Drug: Normal saline Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation Other Names: 0.9% isotonic normal saline
Active Comparator: 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	Drug: Magnesium Sulfate Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation Other Names: 10% magnesium sulfate

Arm

Intervention/Treatment

Placebo Comparator: 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

Drug: Normal saline

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

Other Names:

0.9% isotonic normal saline

Active Comparator: 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

Drug: Magnesium Sulfate

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

Other Names:

10% magnesium sulfate

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 7 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

Principal Investigator: YEA JI LEE, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LEE YEA JI, clinical professor, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT03208452

Other Study ID Numbers:

B1605/346-002

First Posted:

Jul 5, 2017

Last Update Posted:

Apr 7, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Psychomotor Agitation

Emergence Delirium

Magnesium Sulfate

Study Results

No Results Posted as of Apr 7, 2020