Thyroid NeoplasmsNCT02826746
Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy
A study testing Magnesium Sulfate and Normal saline in people with Thyroid Neoplasms, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The primary purpose of this study is to investigate the effect of intravenous magnesium on postoperative throat pain after thyroidectomy. The secondary purpose of this study is to investigate the effect of intravenous magnesium on total dose of fentanyl in recovery room after thyroidectomy. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Thyroid Neoplasms
- 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
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Mar 2019
- 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 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thyroidectomy
Who cannot join
- Allergy to magnesium
- Chronic pain
- Chronic opioid use
- Chronic NSAID use
- Renal dysfunction
- Liver dysfunction
- Cardiac arrythmia
- Seizure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoum
About this study
The primary purpose of this study is to investigate the effect of intravenous magnesium on postoperative throat pain after thyroidectomy.
The secondary purpose of this study is to investigate the effect of intravenous magnesium on total dose of fentanyl in recovery room after thyroidectomy.
- Conditions
- Thyroid Neoplasms
- Being tested
- Magnesium Sulfate, Normal saline
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h
Normal salineDrug
the same bolus and infusion volumes of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Magnesium group | Experimental | intravenous administration of Magnesium Sulfate Receives: Drug: Magnesium Sulfate |
| Control group | Placebo comparator | intravenous administration of normal saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Throat pain
pain assessment using visual analog scale
Measured: Up to 48 hours after surgery end
Secondary outcomes (1)
Fentanyl dose in recovery room
Measured: Up to 30 minutes after surgery end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Eun Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826746
- Sponsor's protocol ID
- AJIRB-MED-CT4-16-089
- Status last verified
- Apr 2019
- First submitted
- 6 Jul 2016
- Last updated
- 5 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy
- ClinicalTrials.gov ID
- NCT02826746
- Acronym / sponsor ID
- AJIRB-MED-CT4-16-089
- Conditions
- Thyroid Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
The primary purpose of this study is to investigate the effect of intravenous magnesium on postoperative throat pain after thyroidectomy.
The secondary purpose of this study is to investigate the effect of intravenous magnesium on total dose of fentanyl in recovery room after thyroidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium group | Experimental | Drug: Magnesium Sulfateintravenous administration of Magnesium Sulfate |
| Control group | Placebo comparator | Drug: Normal salineintravenous administration of normal saline |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Thyroidectomy
Key exclusion criteria (8 listed)
- Allergy to magnesium
- Chronic pain
- Chronic opioid use
- Chronic NSAID use
- Renal dysfunction
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 Sulfateadminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h | Drug | Magnesium group |
| Normal salinethe same bolus and infusion volumes of normal saline | Drug | Control group |
Primary outcome
Throat pain
Time frame: Up to 48 hours after surgery end
pain assessment using visual analog scale
1 secondary outcome
Fentanyl dose in recovery room
Time frame: Up to 30 minutes after surgery end
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 5 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thyroid Neoplasms, run by Ajou University School of Medicine 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 8 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 5 Apr 2019. 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?
Throat pain (time frame: Up to 48 hours after surgery end). 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 5 Apr 2019.