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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-19

Study Completion Date

2018-12-19

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Agitation,Psychomotor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

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

Interventions

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Magnesium Sulfate

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

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10% magnesium sulfate 0.9% isotonic normal saline

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes