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

August 1, 2018 updated by: Hee-Soo Kim, Seoul National University Hospital
Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Magnesium
Mg is administered during anesthesia until 5 minutes before surgery ends
Other Names:
  • Magnesium sulfate
Placebo Comparator: Control group
Saline is administered with same volume of Mg of magnesium group until 5 minutes before surgery ends
Drug: Saline
Same volume of saline is infused until 5 minutes before surgery ends
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence delirium
Time Frame: 30 minutes after anesthesia
Pediatric Anesthesia Emergence Delirium (PAED) scale
30 minutes after anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At each two points: during emergence in operating room and 30 minutes after surgery ends
Nausea
Time Frame: At each two points: during emergence in operating room and 30 minutes after surgery ends
visual analogue scale
At each two points: during emergence in operating room and 30 minutes after surgery ends
vomiting
Time Frame: At each two points: during emergence in operating room and 30 minutes after surgery ends
number
At each two points: during emergence in operating room and 30 minutes after surgery ends
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
During 1 hour after surgery at PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Actual)

December 12, 2017

Study Completion (Actual)

December 12, 2017

Study Registration Dates

First Submitted

April 9, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1703-110-840

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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