Study Results
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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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2011-06-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Physostigmine
Physostigmine
continuous intravenous infusion per syringe pump (13 vials of 2 mg/5 ml --\> 26 mg/65 ml; 1 ml = 0.4 mg Physostigmine) at rate of 1 mg/h (2.5ml/h) for 24 hours
Placebo
Placebo
continuous intravenous infusion of 65 ml NaCl 0.9% with syringe pump at rate of 2.5 ml/h for 24 hours
PCA: Patient-controlled analgesia with hydromorphone 0.2 mg/ml, on demand: bolus of 0.2 mg, maximum 5 boli per hour; 4-hour-maximum 4 mg
Interventions
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Physostigmine
continuous intravenous infusion per syringe pump (13 vials of 2 mg/5 ml --\> 26 mg/65 ml; 1 ml = 0.4 mg Physostigmine) at rate of 1 mg/h (2.5ml/h) for 24 hours
Placebo
continuous intravenous infusion of 65 ml NaCl 0.9% with syringe pump at rate of 2.5 ml/h for 24 hours
PCA: Patient-controlled analgesia with hydromorphone 0.2 mg/ml, on demand: bolus of 0.2 mg, maximum 5 boli per hour; 4-hour-maximum 4 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 50 kg
* Suitable for PCA
* ASA 1-3
Exclusion Criteria
* Iritis
* Stenoses/spasms of intestine, urinary tract, biliary tract
* Closed traumatic brain injury
* Severely reduced left ventricular function (EF\<30%)
* Recent myocardial infarction
* Recent stroke
* Known allergy or hypersensitivity or contraindications against hydromorphone, physostigmine
* History of alcohol or drug abuse
* Patients enrolled in another study
* Women of childbearing age without a negative pregnancy test
18 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Gudrun Rumpold-Seitlinger, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Hospital of the Medical University of Graz
Graz, Styria, Austria
Countries
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Other Identifiers
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2010-021901-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
21-510ex09/10
Identifier Type: -
Identifier Source: org_study_id
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