Pilot Study of Physostigmine-Enhanced Opioid Analgesia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01394445
• Date of registration: 12/07/2011
• Prospective Registration: No
• Primary sponsor: Medical University of Graz
• Public title: Pilot Study of Physostigmine-Enhanced Opioid Analgesia PHANOS
• Scientific title: Influence of Physostigmine on Patient-Controlled Analgesia
• Date of first enrolment: June 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01394445
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Austria

Contacts

• Name: Gudrun Rumpold-Seitlinger, MD
• Affiliation: Medical University of Graz

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative Pain

Intervention(s)

Drug: Physostigmine

Drug: Placebo

Primary Outcome(s)

opioid consumption [Time Frame: 24 hours]

Secondary Outcome(s)

pain scores [Time Frame: 24 hours]

Secondary ID(s)

21-510ex09/10

2010-021901-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors