Pilot Study of Physostigmine-Enhanced Opioid Analgesia

Overview

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

Interventions

  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.