Wirksamkeit und Verträglichkeit von Physostigminsalicylat zur Behandlung des post-operativen Delirs nach Aorto-Koronarer-Bypass-Operatio

• Conditions: Patients with postoperative delirium in the termination phase of anaesthesia after ACVB or aortic valve/mitral valve surgery or double heart intervention (heart-lung-machine (HLM) and mild hypothermia); MedDRA version: 15.1Level: PTClassification code 10012218Term: DeliriumSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2008-006221-14-DE
• Lead Sponsor: Company: Dr. Franz Köhler Chemie GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-06
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Informed Consent),
2.Indication for an elective ACVB or a aortic valve surgery or mitral valve surgery or double heart intervention under use of HLM with mild hypothermia,
3.18 = age < 90,
4.Negative pregnancy test in women with childbearing potential,
5.Ability to understand the meaning of the study.

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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1.Known neurological deficite,
2.Known asthma bronchiale
3.Acute bleeding,
4.Acute renal insufficiency,
5.Use of a ciruculation support system,
6.Body weight >130 kg,
7.Concurrent participation in another interventional clinical trial,
8.Concomittant therapy for cerebral impairment and cerebral circulatory disorders,
9.Known intolerance / hypersensitivity to the IMPs or other compounds with similar chemical structure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified