The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children

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

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2017-12-12

Brief Summary

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Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children

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Detailed Description

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Children \< 8 years old who scheduled for elective opthalmic surgery are randomly assigned to Magnesium (Mg) group and control group. Before anesthetic induction, modified Yale Preoperative Anxiety Scale (m-YPAS) is assessed. Routine anesthetic induction is performed, and neuromuscular blocker is not used. Laryngeal mask airway is inserted and controlled ventilation is started.

In Mg group, Mg of 30 mg/kg is administered for 10 minutes and then continuously infused (10mg/kg/hr) until 5 minutes before surgery end. In control group, the similar volume of saline is infused.

Pediatric Anesthesia Emergence Delirium (PAED) scale and pain score (Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) will be measured immediately after and 30 minutes after surgery.

Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Magnesium group

Mg is administered with dose of 30 mg/kg for 10 minutes and then 10 mg/kg/hr until 5 minutes before surgery ends

Group Type ACTIVE_COMPARATOR

Magnesium

Intervention Type DRUG

Mg is administered during anesthesia until 5 minutes before surgery ends

Control group

Saline is administered with same volume of Mg of magnesium group until 5 minutes before surgery ends

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Same volume of saline is infused until 5 minutes before surgery ends

Interventions

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Magnesium

Mg is administered during anesthesia until 5 minutes before surgery ends

Intervention Type DRUG

Saline

Same volume of saline is infused until 5 minutes before surgery ends

Intervention Type DRUG

Other Intervention Names

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Magnesium sulfate Normal saline

Eligibility Criteria

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Inclusion Criteria

* Children aged between 2 and 7 years
* American Society of Anesthesiologist physical status 1 and 2
* Children scheduled for opthalmic surgery

Exclusion Criteria

* Allergy history to any drugs
* Risk of malignant hyperthermia
* Neuromuscular disease
* With arrhythmia
* Any pulmonary, cardiac, hepatic and renal disease
* Obesity

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes