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Pilot Study of Physostigmine-Enhanced Opioid Analgesia

Information source: Medical University of Graz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Physostigmine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Medical University of Graz

Official(s) and/or principal investigator(s):
Gudrun Rumpold-Seitlinger, MD, Principal Investigator, Affiliation: Medical University of Graz

Summary

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

Clinical Details

Official title: Influence of Physostigmine on Patient-Controlled Analgesia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: opioid consumption

Secondary outcome: pain scores

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Hospital of the Medical University of Graz, Graz, Styria 8036, Austria
Additional Information

Starting date: June 2011
Last updated: February 20, 2012

Page last updated: August 23, 2015

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