CoughPhase 4NCT05237791
Effect of Magnesium on Remifentanil Induced Cough
A Phase 4 study testing Magnesium sulfate in people with Cough, run by Seoul National University Bundang Hospital.
Trial summary
The hypothesis of this study is that Magnesium sulfate pretreatment (50mg/kg) will reduce the incidence of cough and chest wall rigidity caused by remifentanil administration. The purpose of this study was to investigate the effect of magnesium sulfate administered before induction of anesthesia on thoracic stiffness… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cough
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2022to 30 Dec 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-75 years of age who are undergoing surgery under general anesthesia using a laryngeal mask and who have consented to participate in this study among American Society of Anesthesiologists body grade 1 or 2
Who cannot join
- When coughing may occur due to an underlying disease (upper respiratory infection, rhinitis, post nasal drip, asthma, chronic obstructive pulmonary disease, pneumonia, bronchitis, current smokers, etc.)
- If you have kidney disease that can affect magnesium metabolism (glomerular filtration rate less than 60)
- If you are taking opioid analgesics or magnesium for other reasons
- Patients with hypermagnesemia
- Patients with atrioventricular block (stages I-III) or other cardiac conduction disorders
- Pregnant or lactating women
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- Patients with myasthenia gravis
- Patients taking drugs that are contraindicated or interact with magnesium (barbitalates, aminoglycoside antibiotics, isoniazid, chlorpromazine, digoxin)
- In case of hypersensitivity to magnesium
- Patients with a history of hypersensitivity to propofol and any of its components
- Patients with a history of hypersensitivity to remifentanil and other fentanyl analogues
About this study
Official title: Effect of Magnesium Sulfate on Remifentanil Induced Cough and Chest Wall Rigidity
The hypothesis of this study is that Magnesium sulfate pretreatment (50mg/kg) will reduce the incidence of cough and chest wall rigidity caused by remifentanil administration.
The purpose of this study was to investigate the effect of magnesium sulfate administered before induction of anesthesia on thoracic stiffness and cough response caused by opioid analgesics administered for general anesthesia.
- Conditions
- Cough
- Being tested
- Magnesium sulfate, Placebo
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)
PlaceboDrug
normal saline 100ml (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)
| Study group | Role | What they receive |
|---|---|---|
| magnesium group | Experimental | magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion) Receives: Drug: Magnesium sulfate |
| control group | Placebo comparator | normal saline 100ml (loading for 10 minutes), 15mg/kg/hr (continuous infusion) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
remifentanil induced cough
To evaluate whether coughing occurs during anesthesia induction from the start of remifentanil infusion to the completion of laryngeal mask insertion.
Measured: from preoperative 20 minutes to induction of anesthesia
Secondary outcomes (3)
severity of cough
mild: 1-2, moderate: 3-4, severe: ≥ 5
Measured: from preoperative 20 minutes to induction of anesthesia
laryngeal mask airway (LMA) insertion compliance
Assess the number of trials prior to successful laryngeal mask insertion and the need for administration of a neuromuscular blocker.
Measured: from preoperative 20 minutes to induction of anesthesia
lung compliance
Poor compliance of mechanical ventilation is defined as a difference between the set tidal volume and the actual tidal volume value applied to the patient by 100ml or more.
Measured: from induction of anesthesia to finish of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start3 Feb 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiWon Han, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237791
- Sponsor's protocol ID
- B-2201-731-001
- Status last verified
- Feb 2022
- First submitted
- 29 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulfate on Remifentanil Induced Cough and Chest Wall Rigidity
- ClinicalTrials.gov ID
- NCT05237791
- Acronym / sponsor ID
- B-2201-731-001
- Conditions
- Cough
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 3 Feb 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 14 Feb 2022 (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.
The hypothesis of this study is that Magnesium sulfate pretreatment (50mg/kg) will reduce the incidence of cough and chest wall rigidity caused by remifentanil administration.
The purpose of this study was to investigate the effect of magnesium sulfate administered before induction of anesthesia on thoracic stiffness and cough response caused by opioid analgesics administered for general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium group | Experimental | Drug: Magnesium sulfatemagnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion) |
| control group | Placebo comparator | Drug: Placebonormal saline 100ml (loading for 10 minutes), 15mg/kg/hr (continuous infusion) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 20-75 years of age who are undergoing surgery under general anesthesia using a laryngeal mask and who have consented to participate in this study among American Society of Anesthesiologists body grade 1 or 2
Key exclusion criteria (11 listed)
- When coughing may occur due to an underlying disease (upper respiratory infection, rhinitis, post nasal drip, asthma, chronic obstructive pulmonary disease, pneumonia, bronchitis, current smokers, etc.)
- If you have kidney disease that can affect magnesium metabolism (glomerular filtration rate less than 60)
- If you are taking opioid analgesics or magnesium for other reasons
- Patients with hypermagnesemia
- Patients with atrioventricular block (stages I-III) or other cardiac conduction disorders
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 sulfatemagnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion) | Drug | magnesium group |
| Placebonormal saline 100ml (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion) | Drug | control group |
Primary outcome
remifentanil induced cough
Time frame: from preoperative 20 minutes to induction of anesthesia
To evaluate whether coughing occurs during anesthesia induction from the start of remifentanil infusion to the completion of laryngeal mask insertion.
3 secondary outcomes
severity of cough
Time frame: from preoperative 20 minutes to induction of anesthesia
laryngeal mask airway (LMA) insertion compliance
Time frame: from preoperative 20 minutes to induction of anesthesia
lung compliance
Time frame: from induction of anesthesia to finish of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate in people with Cough, run by Seoul National University Bundang Hospital.
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 11 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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
remifentanil induced cough (time frame: from preoperative 20 minutes to induction of anesthesia). 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 14 Feb 2022.