Pilot Study of Physostigmine-Enhanced Opioid Analgesia

Medical University of Graz20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Postoperative Pain

Interventions

PhysostigmineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital of the Medical University of Graz

Graz, Styria, Austria

Outcomes

Primary Outcomes

opioid consumption

Time frame: 24 hours

Secondary Outcomes

pain scores

Time frame: 24 hours

Data from ClinicalTrials.gov

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