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

Primary Purpose

Emergence Delirium

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium
Saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium

Eligibility Criteria

2 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SNUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnesium group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Emergence delirium
Pediatric Anesthesia Emergence Delirium (PAED) scale

Secondary Outcome Measures

Pain score
Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS)
Nausea
visual analogue scale
vomiting
number
Duration of post-anesthetic care unit (PACU) stay
Duration of post-anesthetic care unit (PACU) stay

Full Information

First Posted
April 9, 2017
Last Updated
August 1, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03132701
Brief Title
The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
Official Title
The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium group
Arm Type
Active Comparator
Arm Description
Mg is administered with dose of 30 mg/kg for 10 minutes and then 10 mg/kg/hr until 5 minutes before surgery ends
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Saline is administered with same volume of Mg of magnesium group until 5 minutes before surgery ends
Intervention Type
Drug
Intervention Name(s)
Magnesium
Other Intervention Name(s)
Magnesium sulfate
Intervention Description
Mg is administered during anesthesia until 5 minutes before surgery ends
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal saline
Intervention Description
Same volume of saline is infused until 5 minutes before surgery ends
Primary Outcome Measure Information:
Title
Emergence delirium
Description
Pediatric Anesthesia Emergence Delirium (PAED) scale
Time Frame
30 minutes after anesthesia
Secondary Outcome Measure Information:
Title
Pain score
Description
Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS)
Time Frame
At each two points: during emergence in operating room and 30 minutes after surgery ends
Title
Nausea
Description
visual analogue scale
Time Frame
At each two points: during emergence in operating room and 30 minutes after surgery ends
Title
vomiting
Description
number
Time Frame
At each two points: during emergence in operating room and 30 minutes after surgery ends
Title
Duration of post-anesthetic care unit (PACU) stay
Description
Duration of post-anesthetic care unit (PACU) stay
Time Frame
During 1 hour after surgery at PACU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Soo Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNUH
City
Seoul
State/Province
Jongro Gu
ZIP/Postal Code
15710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33208099
Citation
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.
Results Reference
derived

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

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