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Atrial Fibrillation and Neuropathic Pain After Thoracotomy and Continuous Application of Magnesium Sulphate.

Sponsor
Dr. Horst Schmidt Klinik GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT02008747
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
16
Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Magnesium sulphate
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of Prophylactic Administration of Magnesium Sulfate on the Incidence of Atrial Fibrillation and Chronic Neuropathic Pain After Thoracotomy for Lung Resection.
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Magnesium sulphate

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.

Drug: Magnesium sulphate
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
Other Names:
  • Mg 5 Sulfat 10%

    		•
    No Intervention: No treatment

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of atrial fibrillation [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

    Secondary Outcome Measures

    1. Chronic neuropathic pain [Three months]

      The incidence of neuropathic pain was recorded using the LANSS Score during a period of three months after posterolateral thoracotomy for lung resection.

    Other Outcome Measures

    1. Hypotonia [24 hours perioperative]

      The incidence of hypotonia during the time of continuous magnesium sulphate application was recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years or older

    • posterolateral thoracotomy for lung parenchyma resection

    • informed consent

    Exclusion Criteria:

    • hypersensitivity for magnesium sulphate

    • pre-existing atrial fibrillation

    • participation in another trial

    • pregnancy or breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HSK Wiesbaden Germany 65199

    Sponsors and Collaborators

    • Dr. Horst Schmidt Klinik GmbH

    Investigators

    • Study Chair: Grietje Beck, Prof., HSK Wiesbaden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Horst Schmidt Klinik GmbH
    ClinicalTrials.gov Identifier:
    NCT02008747
    Other Study ID Numbers:
    • HSK 002
    First Posted:
    Dec 11, 2013
    Last Update Posted:
    Dec 11, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Dr. Horst Schmidt Klinik GmbH
    Atrial fibrillation
    Neuropathic pain
    Posterolateral thoracotomy
    Lung resection
    Additional relevant MeSH terms:
    Neuralgia
    Atrial Fibrillation
    Magnesium Sulfate

    Study Results

    No Results Posted as of Dec 11, 2013