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NCT Number: NCT00608621

Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients

The study is to evaluate the influence of physostigmine in the postoperative period in intensive care patients considering pain quality, opioid consumption, hemodynamics and mobilisation.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinkum Ludwigshafen, Department of Anesthesiology

Ludwigshafen, D-67063, Germany

About this study

Pain management is of major concern in the postoperative period, mostly based on opioids. In numerous experimental and clinical trials cholinergic mechanisms have been demonstrated to play an important antinociceptive role. Physostigmine, a central cholineresterase inhibitor, has been shown to produce analgesia and enhance opiate analgesia after systemic injection. This action is not based on µ-receptor (opioid) activity, but can be mostly explained by stimulation of serotonine (5-HT-3) receptors. The major withdrawal of utilizating physostigmine in postoperative care, is due to its short duration of action.

In the present study, we examined the effect of a continuous intavenous physostigmine application during a patient-controlled analgesia with piritramide for 48 hours compared to a placebo infusion with NaCl.

Major concern was set for consumption of analgesics, VAS-pain scale, hemodynamics, mobilisation and side effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-80 years
  • Indication for postoperative pain therapy and admission to ICU
  • ASA I-III
  • Weight 50-125 kg
  • Patients that are willing to participate in the present study

Exclusion criteria

  • Peridural anesthesia for pain management
  • Severe left ventricular function (EF <30%)
  • Severe/exacerbated COPD; Asthma
  • ASA IV-V
  • Chronic renal insufficiency(Creatinine > 1,5 mg/dl)
  • Ulcera ventriculi
  • Known allergy to any of the study agents
  • Hb preoperative <9,5 g/dl
  • Alcohol,drug and/or tablet abuse (Opioids, NSAR)
  • Emergency operation
  • Pregnancy
  • Women of childbearing age and without a negative pregnancy test
  • Severe liver disease (GOT oder GPT > 45 U/L)
  • Severe neurologica derangements (e.g. M. Parkinson, Multiple Sklerosis)
  • History of apoplexia <6 Monate or residua
  • Perioperative myocardial infarction
  • Patients that are not able to agree to the present study
  • Patients that refuse to participate in the present study
  • Patients that are part of any other study

Treatment and study plan

Primary outcomes

  1. opioid consumption

    Time frame: 48 hours

Secondary outcomes

  1. pain quality (VAS) mobilisation hemodynamics side effects

    Time frame: operation to discharge from hospital

Sponsors and collaborators

Lead sponsor

Klinikum Ludwigshafen

Other

Collaborators

  • University of Mannheim

Registry information

Official study title

Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function

Acronym: ANA06103

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 6, 2008
Registry last updated
Feb 6, 2008

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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