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Pilot Study of Physostigmine-Enhanced Opioid Analgesia (PHANOS)

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ClinicalTrials.gov Identifier: NCT01394445
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : February 22, 2012
Sponsor:
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

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

U.S. FDA Resources

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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT01394445


Locations
Austria
Hospital of the Medical University of Graz
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Gudrun Rumpold-Seitlinger, MD Medical University of Graz

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01394445     History of Changes
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:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Physostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents