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Completed

NCT Number: NCT02008747

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HSK

Wiesbaden, 65199, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulphate

Drug

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%

Primary outcomes

  1. 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

Secondary outcomes

  1. Chronic neuropathic pain

    Time frame: 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 outcomes

  1. Hypotonia

    Time frame: 24 hours perioperative

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

Sponsors and collaborators

Lead sponsor

Dr. Horst Schmidt Klinik GmbH

Industry

Registry information

Official study title

Effects of Prophylactic Administration of Magnesium Sulfate on the Incidence of Atrial Fibrillation and Chronic Neuropathic Pain After Thoracotomy for Lung Resection.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2013
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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