Pilot Study of Physostigmine-Enhanced Opioid Analgesia

Phase 3

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Placebo; Drug: Physostigmine

• Registration Number: NCT01394445
• Lead Sponsor: Medical University of Graz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• At least 18 years old
• At least 50 kg
• Suitable for PCA
• ASA 1-3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Physostigmine	Physostigmine	-

Primary Outcome Measures

Name	Time	Method
opioid consumption	24 hours

Secondary Outcome Measures

Name	Time	Method
pain scores	24 hours

Trial Locations

Locations (1)

Hospital of the Medical University of Graz; 🇦🇹 Graz, Styria, Austria