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Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients (ANA06103)

This study has been completed.
Sponsor:
Collaborator:
University of Mannheim
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00608621
First received: January 23, 2008
Last updated: February 5, 2008
Last verified: December 2007
History of Changes
  Purpose

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.


Condition
Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • opioid consumption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain quality (VAS) mobilisation hemodynamics side effects [ Time Frame: operation to discharge from hospital ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1-physostigmine

Physostigmine 4 mg in 50 ml NaCl 0.9% per 24 h as syringe pump continuously for 48 hours, plus physostigmine 2mg (in NaCl 0.9% 50 ml)at termination of sedation

PCA: Patient-controlled analgesia with piritramide 1 mg/ml, on demand: bolus of 2 mg, maximum of 10 mg in 60 min
2-placebo

NaCl 0.9% 50 ml per 24 h continuously over 48 hours, plus 50 ml NaCl 0.9% at termination of sedation

PCA: Patient-controlled analgesia with piritramid 1 mg/ml, on demand: bolus of 2 mg, maximum of 10 mg in 60 min

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Elective major surgery, postoperative ICU patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608621

Locations
Germany
Klinkum Ludwigshafen, Department of Anesthesiology
Ludwigshafen, Germany, D-67063
Sponsors and Collaborators
Klinikum Ludwigshafen
University of Mannheim
Investigators
Principal Investigator: Christoph Konrad, Prof. University Hospital Mannheim, Department of Anesthesiology
Study Director: Kerstin D. Roehm, MD Klinikum Ludwigshafen, Department of Anesthesiology
  More Information

Publications:

Responsible Party: Klinikum Ludwigshafen, Dep. of Anesthesiology, Dr. K. D. Röhm
ClinicalTrials.gov Identifier: NCT00608621     History of Changes
Other Study ID Numbers: ANA06103
Study First Received: January 23, 2008
Last Updated: February 5, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum Ludwigshafen:
physostigmine
postoperative analgesia
pain
patient-controlled analgesia
Opioid consumption
 Pain quality (VAS Score)
Hemodynamics
Mobilisation
Side effects

Additional relevant MeSH terms:
Physostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
 Neurotransmitter Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013