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

NCT ID: NCT02008747

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Neuropathic Pain

Keywords

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Atrial fibrillation Neuropathic pain Posterolateral thoracotomy Lung resection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Magnesium sulphate

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Mg 5 Sulfat 10%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Horst Schmidt Klinik GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grietje Beck, Prof.

Role: STUDY_CHAIR

HSK Wiesbaden

Locations

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HSK

Wiesbaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HSK 002

Identifier Type: -

Identifier Source: org_study_id