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Completed

NCT Number: NCT01394445

Pilot Study of Physostigmine-Enhanced Opioid Analgesia

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital of the Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physostigmine

Drug

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

Drug

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

Other names: sodium chloride, hydal

Primary outcomes

  1. opioid consumption

    Time frame: 24 hours

Secondary outcomes

  1. pain scores

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Influence of Physostigmine on Patient-Controlled Analgesia

Acronym: PHANOS

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 14, 2011
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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