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

Primary Purpose

Atrial Fibrillation, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Magnesium sulphate
Sponsored by
Dr. Horst Schmidt Klinik GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Neuropathic pain, Posterolateral thoracotomy, Lung resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HSK

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Magnesium sulphate

No treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of atrial fibrillation
The incidence of atrial fibrillation was recorded using a 12 lead ECG for a period of 7 days after operation

Secondary Outcome Measures

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.

Full Information

First Posted
November 27, 2013
Last Updated
December 7, 2013
Sponsor
Dr. Horst Schmidt Klinik GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02008747
Brief Title
Atrial Fibrillation and Neuropathic Pain After Thoracotomy and Continuous Application of Magnesium Sulphate.
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Horst Schmidt Klinik GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Neuropathic Pain
Keywords
Atrial fibrillation, Neuropathic pain, Posterolateral thoracotomy, Lung resection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium sulphate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulphate
Other Intervention Name(s)
Mg 5 Sulfat 10%
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of atrial fibrillation
Description
The incidence of atrial fibrillation was recorded using a 12 lead ECG for a period of 7 days after operation
Time Frame
Up to 168 hours after operation
Secondary Outcome Measure Information:
Title
Chronic neuropathic pain
Description
The incidence of neuropathic pain was recorded using the LANSS Score during a period of three months after posterolateral thoracotomy for lung resection.
Time Frame
Three months
Other Pre-specified Outcome Measures:
Title
Hypotonia
Description
The incidence of hypotonia during the time of continuous magnesium sulphate application was recorded.
Time Frame
24 hours perioperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grietje Beck, Prof.
Organizational Affiliation
HSK Wiesbaden
Official's Role
Study Chair
Facility Information:
Facility Name
HSK
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany

12. IPD Sharing Statement

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

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