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NCT03132701 Clinical Trial

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

Emergence Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03132701
Other study ID # H1703-110-840
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2017
Est. completion date December 12, 2017

Study information
Verified date August 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date December 12, 2017
Est. primary completion date December 12, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 7 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesium
Mg is administered during anesthesia until 5 minutes before surgery ends
• Saline
Same volume of saline is infused until 5 minutes before surgery ends

Locations
Country Name City State
Korea, Republic of SNUH Seoul Jongro Gu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Emergence delirium Pediatric Anesthesia Emergence Delirium (PAED) scale 30 minutes after anesthesia
Secondary Pain score Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) At each two points: during emergence in operating room and 30 minutes after surgery ends
Secondary Nausea visual analogue scale At each two points: during emergence in operating room and 30 minutes after surgery ends
Secondary vomiting number At each two points: during emergence in operating room and 30 minutes after surgery ends
Secondary Duration of post-anesthetic care unit (PACU) stay Duration of post-anesthetic care unit (PACU) stay During 1 hour after surgery at PACU
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