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Pilot Study of Physostigmine-Enhanced Opioid Analgesia (PHANOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01394445
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Physostigmine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Physostigmine on Patient-Controlled Analgesia
Study Start Date : June 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Physostigmine Drug: Physostigmine
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

Placebo Comparator: Placebo Drug: Placebo

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

Other Names:
  • sodium chloride
  • hydal

Primary Outcome Measures :
  1. opioid consumption [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. pain scores [ Time Frame: 24 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01394445

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Hospital of the Medical University of Graz
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Gudrun Rumpold-Seitlinger, MD Medical University of Graz
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Responsible Party: Medical University of Graz Identifier: NCT01394445    
Other Study ID Numbers: 21-510ex09/10
2010-021901-19 ( EudraCT Number )
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents