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

NCT02008747 | Completed

• 1 other identifier: HSK 002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Neuropathic Pain

Keywords

Atrial fibrillation; Neuropathic pain; Posterolateral thoracotomy; Lung resection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Chronic neuropathic pain

  Three months

Other Outcomes (1)

• Hypotonia

  24 hours perioperative

Study Arms (2)

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.

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.

Interventions

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

Also known as: Mg 5 Sulfat 10%

Magnesium sulphate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• posterolateral thoracotomy for lung parenchyma resection
• informed consent

You may not qualify if:

• hypersensitivity for magnesium sulphate
• pre-existing atrial fibrillation
• participation in another trial
• pregnancy or breastfeeding

Sponsors & Collaborators

• Dr. Horst Schmidt Klinik GmbH: lead

Study Sites (1)

HSK

Wiesbaden, 65199, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation; Neuralgia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Grietje Beck, Prof.

  HSK Wiesbaden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 11, 2013
• Study Start: January 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

DE (1)