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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-007174-35-DE
Enrollment
Unknown
Registered
2008-11-05
Start date
Unknown
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Anticholium Product Name: Physostigmin Product Code: 6073341.00.00 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Physostigminsalicylat CAS Number: 57-47-6 Concentration un

Sponsors

Dr. Franz Köhler Chemie GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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). CRP, procalcitonin, body temperature SIRS criteria Blood count (leucocytes, platelets, Hb content) Hemodynamic parameters (heart rate, blood pressure, probably cardiac output) ScvO2 Catecholamine demand Bilirubin, creatine, ASAT, gamma-GT Blood gases Quantification of the post-operative analgesic demand Quantification of pain intensity Quantification of post-operative nausea Acquisition of health-related quality of life (SF36) ;Primary end point(s): Improvement of the post-operative vigilance and cognitive functions—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026