Pilot Study of Physostigmine-Enhanced Opioid Analgesia (PHANOS)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Physostigmine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Hospital of the Medical University of Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Physostigmine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
opioid consumption
Secondary Outcome Measures
pain scores
Full Information
NCT ID
NCT01394445
First Posted
July 12, 2011
Last Updated
February 20, 2012
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT01394445
Brief Title
Pilot Study of Physostigmine-Enhanced Opioid Analgesia
Acronym
PHANOS
Official Title
Influence of Physostigmine on Patient-Controlled Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physostigmine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Physostigmine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sodium chloride, hydal
Intervention Description
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
Primary Outcome Measure Information:
Title
opioid consumption
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
pain scores
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gudrun Rumpold-Seitlinger, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
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Pilot Study of Physostigmine-Enhanced Opioid Analgesia
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