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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2007

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.

Arms, Groups and 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

Clinical Trial Outcome Measures

Primary Measures

  • opioid consumption
    • Time Frame: 48 hours

Secondary Measures

  • pain quality (VAS) mobilisation hemodynamics side effects
    • Time Frame: operation to discharge from hospital

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Klinikum Ludwigshafen
  • Collaborator
    • University of Mannheim
  • Provider of Information About this Clinical Study
    • Klinikum Ludwigshafen, Dep. of Anesthesiology, Dr. K. D. Röhm
  • Overall Official(s)
    • Christoph Konrad, Prof., Principal Investigator, University Hospital Mannheim, Department of Anesthesiology
    • Kerstin D. Roehm, MD, Study Director, Klinikum Ludwigshafen, Department of Anesthesiology

References

Beilin B, Bessler H, Papismedov L, Weinstock M, Shavit Y. Continuous physostigmine combined with morphine-based patient-controlled analgesia in the postoperative period. Acta Anaesthesiol Scand. 2005 Jan;49(1):78-84.

Röhm KD, Riechmann J, Boldt J, Schöllhorn T, Piper SN. Retracted: Do patients profit from physostigmine in recovery from desflurane anaesthesia? Acta Anaesthesiol Scand. 2007 Mar;51(3):278-83. Epub 2007 Jan 23.

Aiello-Malmberg P, Bartolini A, Bartolini R, Galli A. Effects of morphine, physostigmine and raphe nuclei stimulation on 5-hydroxytryptamine release from the cerebral cortex of the cat. Br J Pharmacol. 1979 Apr;65(4):547-55.

Passchier J, Rupreht J, Koenders ME, Olree M, Luitwieler RL, Bonke B. Patient-controlled analgesia (PCA) leads to more postoperative pain relief, but also to more fatigue and less vigour. Acta Anaesthesiol Scand. 1993 Oct;37(7):659-63.

Rupreht J, Schneck HJ, Dworacek B. [Physostigmine–recent pharmacologic data and their significance for practical use]. Anaesthesiol Reanim. 1989;14(4):235-41. Review. German.

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