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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
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 12, 2011
Last Updated
February 20, 2012
Sponsor
Medical University of Graz
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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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