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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008747
• Other study ID #: HSK 002
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: December 7, 2013
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2013
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
Germany	HSK	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypotonia	The incidence of hypotonia during the time of continuous magnesium sulphate application was recorded.	24 hours perioperative	No
Primary	Incidence of atrial fibrillation	The incidence of atrial fibrillation was recorded using a 12 lead ECG for a period of 7 days after operation	Up to 168 hours after operation	No
Secondary	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.	Three months	No