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

December 7, 2013 updated by: Dr. Horst Schmidt Klinik GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wiesbaden, Germany, 65199
        • HSK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 168 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotonia
Time Frame: 24 hours perioperative
The incidence of hypotonia during the time of continuous magnesium sulphate application was recorded.
24 hours perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Horst Schmidt Klinik GmbH

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 7, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 7, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSK 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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