Postoperative Pain
Conditions
Brief summary
The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.
Interventions
DRUGPhysostigmine
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
DRUGPlacebo
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
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old * At least 50 kg * Suitable for PCA * ASA 1-3
Exclusion criteria
* Bronchial asthma/severe or exacerbated COPD * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| opioid consumption | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| pain scores | 24 hours |
Countries
Austria
Outcome results
None listed