Pilot Study of Physostigmine-Enhanced Opioid Analgesia (PHANOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01394445
First received: July 12, 2011
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Postoperative Pain
Drug: Physostigmine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Physostigmine on Patient-Controlled Analgesia

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01394445     History of Changes
Other Study ID Numbers: 21-510ex09/10, 2010-021901-19
Study First Received: July 12, 2011
Last Updated: February 20, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Physostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014