Randomized, placebo-controlled phase-IV clinical trial for the application of physostigmine salicylate for an early post-operative restoration of vigilance and cognition after cardiopulmonary bypass surgery: Recording of additional analgetic and anti-inflammatory active components.

Conditions: post-operative restoration of vigilance and cognition after cardiopulmonary bypass surgery
MedDRA version: 9.1Level: LLTClassification code 10066123Term: Cardiopulmonary bypass

Registration Number: EUCTR2007-007174-35-DE

Lead Sponsor: Dr. Franz Köhler Chemie GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Elective cardiosurgery (bypass surgery / prosthetic heart valve or reconstruction of the heat valve)
-ASA classification II and III
-Being of legal age
-Written informed consent to participate in the clinical trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known contraindication to physostigmine salicylate, such as bronchial asthma or hypersensitivity to sulfites
2.Stenoses of the intestinal tract and the bile ducts
3.Pregnancy
4.Neurological diseases
5.Left ventricular ejection fraction < 40 %
6.Simultaneous participation in other clinical trials or participation in other clinical trials within the last 30 days.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Improvement of the post-operative vigilance and cognitive functions after cardiosurgeries.;Secondary Objective: Reduction of the systemic inflammatory response after cardiosurgeries with extra-corporal circulation which is to be quantified by the examination of the pro-inflam¬ma¬¬tory and anti-inflammatory genes of immunocompetent cells in the serum (microarray).<br><br>CRP, procalcitonin, body temperature<br>SIRS criteria<br>Blood count (leucocytes, platelets, Hb content) <br>Hemodynamic parameters (heart rate, blood pressure, probably cardiac output)<br>ScvO2<br>Catecholamine demand<br>Bilirubin, creatine, ASAT, gamma-GT<br>Blood gases<br>Quantification of the post-operative analgesic demand<br>Quantification of pain intensity<br>Quantification of post-operative nausea<br>Acquisition of health-related quality of life (SF36)<br>;Primary end point(s): Improvement of the post-operative vigilance and cognitive functions

Secondary Outcome Measures