Emergence DeliriumNCT03132701
The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
A study testing Magnesium and Saline in people with Emergence Delirium, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Magnesium and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2017to 12 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 2 and 7 years
- American Society of Anesthesiologist physical status 1 and 2
- Children scheduled for opthalmic surgery
Who cannot join
- Allergy history to any drugs
- Risk of malignant hyperthermia
- Neuromuscular disease
- With arrhythmia
- Any pulmonary, cardiac, hepatic and renal disease
- Obesity
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children
Read the 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.
- Conditions
- Emergence Delirium
- Being tested
- Magnesium, Saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDrug
Also called Magnesium sulfate
Mg is administered during anesthesia until 5 minutes before surgery ends
SalineDrug
Also called Normal saline
Same volume of saline is infused until 5 minutes before surgery ends
| Study group | Role | What they receive |
|---|---|---|
| Magnesium group | Active comparator | Mg is administered with dose of 30 mg/kg for 10 minutes and then 10 mg/kg/hr until 5 minutes before surgery ends Receives: Drug: Magnesium |
| Control group | Placebo comparator | Saline is administered with same volume of Mg of magnesium group until 5 minutes before surgery ends Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence delirium
Pediatric Anesthesia Emergence Delirium (PAED) scale
Measured: 30 minutes after anesthesia
Secondary outcomes (4)
Pain score
Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS)
Measured: At each two points: during emergence in operating room and 30 minutes after surgery ends
Nausea
visual analogue scale
Measured: At each two points: during emergence in operating room and 30 minutes after surgery ends
vomiting
number
Measured: At each two points: during emergence in operating room and 30 minutes after surgery ends
Duration of post-anesthetic care unit (PACU) stay
Duration of post-anesthetic care unit (PACU) stay
Measured: During 1 hour after surgery at PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start8 Jun 2017
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132701
- Sponsor's protocol ID
- H1703-110-840
- Status last verified
- Aug 2018
- First submitted
- 9 Apr 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33208099
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children
- ClinicalTrials.gov ID
- NCT03132701
- Acronym / sponsor ID
- H1703-110-840
- Conditions
- Emergence Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium group | Active comparator | Drug: MagnesiumMg 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 comparator | Drug: SalineSaline is administered with same volume of Mg of magnesium group until 5 minutes before surgery ends |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 2 and 7 years
- American Society of Anesthesiologist physical status 1 and 2
- Children scheduled for opthalmic surgery
Key exclusion criteria (6 listed)
- Allergy history to any drugs
- Risk of malignant hyperthermia
- Neuromuscular disease
- With arrhythmia
- Any pulmonary, cardiac, hepatic and renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnesiumAlso: Magnesium sulfateMg is administered during anesthesia until 5 minutes before surgery ends | Drug | Magnesium group |
| SalineAlso: Normal salineSame volume of saline is infused until 5 minutes before surgery ends | Drug | Control group |
Primary outcome
Emergence delirium
Time frame: 30 minutes after anesthesia
Pediatric Anesthesia Emergence Delirium (PAED) scale
4 secondary outcomes
Pain score
Time frame: 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
vomiting
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 33208099Lee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Soo Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium and Saline in people with Emergence Delirium, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence delirium (time frame: 30 minutes after anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.