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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02008747
Other study ID # HSK 002
Secondary ID
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


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
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