Pilot Study of Physostigmine-Enhanced Opioid Analgesia
PHANOS
Influence of Physostigmine on Patient-Controlled Analgesia
2 other identifiers
interventional
20
1 country
1
Brief Summary
The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 postoperative-pain
Started Jun 2011
Shorter than P25 for phase_3 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 22, 2012
February 1, 2012
6 months
July 12, 2011
February 20, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
opioid consumption
24 hours
Secondary Outcomes (1)
pain scores
24 hours
Study Arms (2)
Physostigmine
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- At least 18 years old
- At least 50 kg
- Suitable for PCA
- ASA 1-3
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the Medical University of Graz
Graz, Styria, 8036, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gudrun Rumpold-Seitlinger, MD
Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 14, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 22, 2012
Record last verified: 2012-02