Pilot Study of Physostigmine-Enhanced Opioid Analgesia (PHANOS)

Medical University of Graz

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Physostigmine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01394445

21-510ex09/10

2010-021901-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Physostigmine

Active Comparator group

Treatment:

Drug: Physostigmine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo