Atrial FibrillationNCT02008747
Atrial Fibrillation and Neuropathic Pain After Thoracotomy and Continuous Application of Magnesium Sulphate.
A study testing Magnesium sulphate in people with Atrial Fibrillation and Neuropathic Pain, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
Trial summary
Atrial fibrillation and chronic neuropathic pain are adverse events occurring after posterolateral thoracotomy for lung resection. The continuous application of magnesium sulphate may have a prophylactic effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Neuropathic Pain
- What is being tested?
- Magnesium sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to May 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- posterolateral thoracotomy for lung parenchyma resection
- informed consent
Who cannot join
- hypersensitivity for magnesium sulphate
- pre-existing atrial fibrillation
- participation in another trial
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Prophylactic Administration of Magnesium Sulfate on the Incidence of Atrial Fibrillation and Chronic Neuropathic Pain After Thoracotomy for Lung Resection.
Atrial fibrillation and chronic neuropathic pain are adverse events occurring after posterolateral thoracotomy for lung resection. The continuous application of magnesium sulphate may have a prophylactic effect. The investigators record the incidence of atrial fibrillation during a seven day period after thoracotomy as well as the incidence of chronic neuropathic pain during a three months period, comparing one group with a continuous application of magnesium sulphate against one group without magnesium sulphate.
- Conditions
- Atrial Fibrillation, Neuropathic Pain
- Being tested
- Magnesium sulphate
- Keywords
- Atrial fibrillation, Neuropathic pain, Posterolateral thoracotomy, Lung resection
- Medical subject headings
- Atrial Fibrillation, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
Also called Mg 5 Sulfat 10%
Continuous application of magnesium sulphate applied 40 mg/kg ideal body weight by bolus before the operation started, followed by a continuous infusion of 10 mg/kg ideal body weight/h for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate | Active comparator | The patients in this group underwent general anaesthesia with total intravenous anesthesia containing Remifentanyl (0,3 mg/kg ideal body weight/h), Propofol (4 mg/kg ideal body weight/h) and Atracurium.
They also received 40mg/kg ideal body weight magnesium sulphate by bolus injection before the operation started, followed by a continuous application of 10mg/kg ideal body weight/hour for 24 hours. Receives: Drug: Magnesium sulphate |
| No treatment | No intervention | The patients in this group underwent general anaesthesia with total intravenous anesthesia containing Remifentanyl (0,3 mg/kg ideal body weight/h), Propofol (4 mg/kg ideal body weight/h) and Atracurium. They received no additional medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial fibrillation
The incidence of atrial fibrillation was recorded using a 12 lead ECG for a period of 7 days after operation
Measured: Up to 168 hours after operation
Secondary outcomes (1)
Chronic neuropathic pain
The incidence of neuropathic pain was recorded using the LANSS Score during a period of three months after posterolateral thoracotomy for lung resection.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grietje Beck, Prof., Study chair, HSK Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008747
- Sponsor's protocol ID
- HSK 002
- Status last verified
- Dec 2013
- First submitted
- 27 Nov 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prophylactic Administration of Magnesium Sulfate on the Incidence of Atrial Fibrillation and Chronic Neuropathic Pain After Thoracotomy for Lung Resection.
- ClinicalTrials.gov ID
- NCT02008747
- Acronym / sponsor ID
- HSK 002
- Conditions
- Atrial Fibrillation, Neuropathic Pain
- Keywords
- Atrial fibrillation, Neuropathic pain, Posterolateral thoracotomy, Lung resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Dec 2013 (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.
Atrial fibrillation and chronic neuropathic pain are adverse events occurring after posterolateral thoracotomy for lung resection. The continuous application of magnesium sulphate may have a prophylactic effect. The investigators record the incidence of atrial fibrillation during a seven day period after thoracotomy as well as the incidence of chronic neuropathic pain during a three months period, comparing one group with a continuous application of magnesium sulphate against one group without magnesium sulphate.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate | Active comparator | Drug: Magnesium sulphateThe patients in this group underwent general anaesthesia with total intravenous anesthesia containing Remifentanyl (0,3 mg/kg ideal body weight/h), Propofol (4 mg/kg ideal body weight/h) and Atracurium. They also received 40mg/kg ideal body weight magnesium sulphate by bolus injection before the operation started, followed by a continuous application of 10mg/kg ideal body weight/hour for 24 hours. |
| No treatment | No intervention | –The patients in this group underwent general anaesthesia with total intravenous anesthesia containing Remifentanyl (0,3 mg/kg ideal body weight/h), Propofol (4 mg/kg ideal body weight/h) and Atracurium. They received no additional medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- posterolateral thoracotomy for lung parenchyma resection
- informed consent
Key exclusion criteria (4 listed)
- hypersensitivity for magnesium sulphate
- pre-existing atrial fibrillation
- participation in another trial
- pregnancy or breastfeeding
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 sulphateAlso: Mg 5 Sulfat 10%Continuous application of magnesium sulphate applied 40 mg/kg ideal body weight by bolus before the operation started, followed by a continuous infusion of 10 mg/kg ideal body weight/h for 24 hours | Drug | Magnesium sulphate |
Primary outcome
Incidence of atrial fibrillation
Time frame: Up to 168 hours after operation
The incidence of atrial fibrillation was recorded using a 12 lead ECG for a period of 7 days after operation
1 secondary outcome
Chronic neuropathic pain
Time frame: Three months
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 11 Dec 2013.
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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.
Grietje Beck, Prof. study chair
HSK Wiesbaden
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 sulphate in people with Atrial Fibrillation and Neuropathic Pain, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
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 4 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 11 Dec 2013. 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 Germany. 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. 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?
Incidence of atrial fibrillation (time frame: Up to 168 hours after operation). 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 11 Dec 2013.