Postoperative PainNCT03206008
The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery
A study testing Magnesium Sulfate and Normal saline in people with Postoperative Pain, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient surgery case Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Magnesium Sulfate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Nov 2016to 24 Nov 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 18-65 year-old-patient (ASA I-II) who are planned to undergoing day surgery
Who cannot join
- ASA class ≥ III
- suspected imbalance of electrolyte
- myocardial damage or conduction delay
- myasthenia gravis or other neuromuscular disease
- impaired renal function
- already using any type of analgesia
- denial of participating in the study or not giving the informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital, department of Anesthesia and pain
Seongnam, Gyenggo-do, 13620
About this study
Official title: The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery After Outpatient Surgery
Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient surgery case
- Conditions
- Postoperative Pain
- Being tested
- Magnesium Sulfate, Normal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Normal salineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Normal saline group | Placebo comparator | after loading normal saline 100cc in 10-20 minutes, continuous infusion of normal saline until the end of surgery Receives: Drug: Normal saline |
| Magnesium group | Active comparator | after loading magnesium sulfate dosing 50 mg/kg (100cc) in 10-20 minutes, continuous infusion of magnesium sulfate 15 mg/kg/h until the end of surgery Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of postoperative pain
checking the postoperative pain in score at the recovery room and outpatient surgery center
Measured: 1 hour interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start18 Nov 2016
- Primary completion24 Nov 2017
- Study completion24 Nov 2017
Why it stopped: hard to get an informed concent because of small number of indiaiton of surgery
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE YEA JI, Seoul National University Bundang Hospital
- Investigators
- SangHwan Do, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206008
- Sponsor's protocol ID
- B-1608-360-006
- Status last verified
- Apr 2018
- First submitted
- 30 Jun 2017
- Last updated
- 20 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery After Outpatient Surgery
- ClinicalTrials.gov ID
- NCT03206008
- Acronym / sponsor ID
- B-1608-360-006
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: hard to get an informed concent because of small number of indiaiton of surgery
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 24 Nov 2017 (actual)
- First posted
- 2 Jul 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.
Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient surgery case
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline group | Placebo comparator | Drug: Normal salineafter loading normal saline 100cc in 10-20 minutes, continuous infusion of normal saline until the end of surgery |
| Magnesium group | Active comparator | Drug: Magnesium Sulfateafter loading magnesium sulfate dosing 50 mg/kg (100cc) in 10-20 minutes, continuous infusion of magnesium sulfate 15 mg/kg/h until the end of surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged between 18-65 year-old-patient (ASA I-II) who are planned to undergoing day surgery
Key exclusion criteria (7 listed)
- ASA class ≥ III
- suspected imbalance of electrolyte
- myocardial damage or conduction delay
- myasthenia gravis or other neuromuscular disease
- impaired renal function
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 |
|---|---|---|
| Magnesium Sulfate | Drug | Magnesium group |
| Normal salinePlacebo | Drug | Normal saline group |
Primary outcome
severity of postoperative pain
Time frame: 1 hour interval
checking the postoperative pain in score at the recovery room and outpatient surgery center
Results and safety
The study was stopped early (reason given: hard to get an informed concent because of small number of indiaiton of surgery). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: No
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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.
SangHwan Do study chair
Seoul National University Bundang 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 Sulfate and Normal saline in people with Postoperative Pain, run by Seoul National University Bundang 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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Apr 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 was stopped early (reason given: hard to get an informed concent because of small number of indiaiton of surgery). Results are not available in the source record.
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?
severity of postoperative pain (time frame: 1 hour interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2018.