Pilot Study of Physostigmine-Enhanced Opioid Analgesia

Postoperative Pain Clinical Trial

— PHANOS  

Official title:

Influence of Physostigmine on Patient-Controlled Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394445
• Other study ID #: 21-510ex09/10
• Secondary ID: 2010-021901-19
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2011
• Last updated: February 20, 2012
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Physostigmine
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
• Placebo
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

Locations

Country	Name	City	State
Austria	Hospital of the Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption		24 hours	No
Secondary	pain scores		24 hours	No