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Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy (atropinePEI)

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ClinicalTrials.gov Identifier: NCT00575523
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:
Medical University of Vienna

Brief Summary:
Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied by clinical complications such as unconsciousness, respiratory arrest or seizure like symptoms. Study purpose is to evaluate whether the use of i.v. Atropine before starting ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized, placebo controlled, double blinded study. Atropine or saline solution will be administered intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A 6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal possibly occurring dysrhythmias.

Condition or disease Intervention/treatment Phase
Arrhythmia Respiratory Arrest Drug: Atropine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Study Start Date : October 2003
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1: Atropine
Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation.
Drug: Atropine
Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.

Placebo Comparator: 2: Placebo
1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
Drug: Placebo
1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.




Primary Outcome Measures :
  1. Occurrence of dysrhythmias [ Time Frame: during percutaneous ethanol instillation ]

Secondary Outcome Measures :
  1. Clinical complications [ Time Frame: during percutaneous ethanol instillation and consecutive 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation

Exclusion Criteria:

  • contraindication for the administration of atropine like
  • narrow angle glaucoma
  • mechanic stenoses of the GI-tract
  • clinically relevant prostatic hypertrophy
  • paralytic ileus
  • myasthenia gravis
  • severe cerebral sclerosis
  • acute lung edema
  • acute myocardial infarction
  • cardiac insufficiency
  • hyperthyroidism
  • patients with contraindication to undergo percutaneous ethanol instillation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575523


Locations
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Austria
Div. of Gastroenterology and Hepatology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arnulf Ferlitsch, MD, Gastroenterology and Hepatology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00575523     History of Changes
Other Study ID Numbers: atropinePEI
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008
Keywords provided by Medical University of Vienna:
atropine
percutaneous ethanol instillation
hepatoma
bradycardia
arrhythmia
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Apnea
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Ethanol
Atropine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics