NCT01394445CompletedPhase 3
Influence of Physostigmine on Patient-Controlled Analgesia
Medical University of Graz1 site in 1 country20 target enrollmentStarted: June 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- opioid consumption
Study Overview
Brief Summary
The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years old
- •At least 50 kg
- •Suitable for PCA
Exclusion Criteria
- •Bronchial asthma/severe or exacerbated COPD
- •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
Arms & Interventions
Physostigmine
Active Comparator
Intervention: Physostigmine (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
opioid consumption
Time Frame: 24 hours
Secondary Outcomes
- pain scores(24 hours)
Investigators
Study Sites (1)
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