Pilot Study of Physostigmine-Enhanced Opioid Analgesia (PHANOS)

Influence of Physostigmine on Patient-Controlled Analgesia

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Physostigmine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Hospital of the Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
opioid consumption	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
pain scores	24 hours

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Gudrun Rumpold-Seitlinger, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (Estimate): July 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 20, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Miotics; Physostigmine
• Other Study ID Numbers: 21-510ex09/10; 2010-021901-19 (EudraCT Number)