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

NCT03208452 | Completed Phase 4

• 1 other identifier: B1605/346-002
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Agitation,Psychomotor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the severity of EA

  15 minute interval at the post-anesthetic care unit (PACU)

Study Arms (2)

Normal saline(NS) group

PLACEBO COMPARATOR

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

Magnesium group

ACTIVE COMPARATOR

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

Interventions

Magnesium Sulfate DRUG

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

Also known as: 10% magnesium sulfate

Magnesium group

Normal saline DRUG

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

Also known as: 0.9% isotonic normal saline

Normal saline(NS) group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• pediatric patients who are planned to operate ophthalmic surgery under general anesthesia aged 4-7 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• YEA JI LEE

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 5, 2017
• Study Start: March 19, 2017
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)