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

Pain Clinical Trial

— ANA06103  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608621
• Other study ID #: ANA06103
• Status: Completed
• Phase: N/A
• First received: January 23, 2008
• Last updated: February 5, 2008
• Start date: January 2007
• Est. completion date: October 2007

Study information

• Verified date: December 2007
• Source: Klinikum Ludwigshafen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
Germany	Klinkum Ludwigshafen, Department of Anesthesiology	Ludwigshafen

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Ludwigshafen	University of Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption		48 hours	No
Secondary	pain quality (VAS) mobilisation hemodynamics side effects		operation to discharge from hospital	No