The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
1 other identifier
interventional
66
1 country
1
Brief Summary
Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedStudy Start
First participant enrolled
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2017
CompletedAugust 2, 2018
August 1, 2018
6 months
April 9, 2017
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Emergence delirium
Pediatric Anesthesia Emergence Delirium (PAED) scale
30 minutes after anesthesia
Secondary Outcomes (4)
Pain score
At each two points: during emergence in operating room and 30 minutes after surgery ends
Nausea
At each two points: during emergence in operating room and 30 minutes after surgery ends
vomiting
At each two points: during emergence in operating room and 30 minutes after surgery ends
Duration of post-anesthetic care unit (PACU) stay
During 1 hour after surgery at PACU
Study Arms (2)
Magnesium group
ACTIVE COMPARATORMg is administered with dose of 30 mg/kg for 10 minutes and then 10 mg/kg/hr until 5 minutes before surgery ends
Control group
PLACEBO COMPARATORSaline is administered with same volume of Mg of magnesium group until 5 minutes before surgery ends
Interventions
Eligibility Criteria
You may qualify if:
- Children aged between 2 and 7 years
- American Society of Anesthesiologist physical status 1 and 2
- Children scheduled for opthalmic surgery
You may not qualify if:
- Allergy history to any drugs
- Risk of malignant hyperthermia
- Neuromuscular disease
- With arrhythmia
- Any pulmonary, cardiac, hepatic and renal disease
- Obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNUH
Seoul, Jongro Gu, 15710, South Korea
Related Publications (1)
Lee JH, Choi S, Lee M, Jang YE, Kim EH, Kim JT, Kim HS. Effect of magnesium supplementation on emergence delirium and postoperative pain in children undergoing strabismus surgery: a prospective randomised controlled study. BMC Anesthesiol. 2020 Nov 18;20(1):289. doi: 10.1186/s12871-020-01192-7.
PMID: 33208099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Soo Kim
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 9, 2017
First Posted
April 28, 2017
Study Start
June 8, 2017
Primary Completion
December 12, 2017
Study Completion
December 12, 2017
Last Updated
August 2, 2018
Record last verified: 2018-08