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

Primary Purpose

Agitation,Psychomotor

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal saline
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation,Psychomotor

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Normal saline(NS) group

Magnesium group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the severity of EA
Comparing the maximal PAED score between the placebo group and the intervention group for evaluating difference of severity of EA.

Full Information

First Posted
June 30, 2017
Last Updated
September 6, 2023
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03208452
Brief Title
The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation
Official Title
The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation After Pediatric Ophthalmic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2017 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation,Psychomotor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline(NS) group
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Magnesium group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
10% magnesium sulfate
Intervention Description
Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% isotonic normal saline
Intervention Description
Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation
Primary Outcome Measure Information:
Title
the incidence of emergence agitation (EA)
Description
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.
Time Frame
15 minute interval at the post-anesthetic care unit (PACU)
Secondary Outcome Measure Information:
Title
the severity of EA
Description
Comparing the maximal PAED score between the placebo group and the intervention group for evaluating difference of severity of EA.
Time Frame
15 minute interval at the post-anesthetic care unit (PACU)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YEA JI LEE
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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