Pilot Study of Physostigmine-Enhanced Opioid Analgesia


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

Full Title of Study: “Influence of Physostigmine on Patient-Controlled Analgesia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2011


  • 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
  • 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

Arms, Groups and Cohorts

  • Active Comparator: Physostigmine
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • opioid consumption
    • Time Frame: 24 hours

Secondary Measures

  • pain scores
    • Time Frame: 24 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Graz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gudrun Rumpold-Seitlinger, MD, Principal Investigator, Medical University of Graz

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