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Completed

NCT Number: NCT03132701

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

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

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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUH

Seoul, Jongro Gu, 15710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium

Drug

Mg is administered during anesthesia until 5 minutes before surgery ends

Other names: Magnesium sulfate

Saline

Drug

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

Other names: Normal saline

Primary outcomes

  1. Emergence delirium

    Time frame: 30 minutes after anesthesia

    Pediatric Anesthesia Emergence Delirium (PAED) scale

Secondary outcomes

  1. Pain score

    Time frame: At each two points: during emergence in operating room and 30 minutes after surgery ends

    Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS)

  2. Nausea

    Time frame: At each two points: during emergence in operating room and 30 minutes after surgery ends

    visual analogue scale

  3. vomiting

    Time frame: At each two points: during emergence in operating room and 30 minutes after surgery ends

    number

  4. Duration of post-anesthetic care unit (PACU) stay

    Time frame: During 1 hour after surgery at PACU

    Duration of post-anesthetic care unit (PACU) stay

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2017
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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