Neuroprotection With Dexmedetomidine in Patients Undergoing Elective Cardiac or Abdominal Surgery (Neuprodex)

Study Group:

Inclusion criteria

• Patients aged ≥ 60 years
• Male and female patients undergoing elective cardiac (elective CABG-surgery without valve surgery with left ventricular ejection fraction ≥ 30%) or pancreatic or hepatic or gastric or intestinal surgery of both Campus Charité Mitte and Campus Virchow - Klinikum, Charité - Universitätsmedizin Berlin
• Offered patient information and written consent by the patient (according to German Drug Law § 40 (1) 3b)
• Premedication only with benzodiazepines
• Pain therapy during the operation with regional procedures and/or Sufentanil/Fentanyl
• Anesthesia in cardio surgery according to Heart-Lung-Apparatus
• Anesthesia with hypnotic agent Propofol
• Pain therapy after operation according to S3-Guideline
• Postoperative medication for anxiolysis only with benzodiazepines

Exclusion criteria

• Known drug intolerance/allergy: dexmedetomidine or to other ingredients
• Lacking willingness to save and hand out pseudonymised data within the clinical trial
• Accommodation in an institution due to an official or judicial order (according to AMG §40 (1) 4)
• Employee of the Charité - Universitätsmedizin Berlin CVK/CCM
• Illiteracy
• Inability to speak and/or read German
• Minimal mental status examination (MMSE) < 24
• Severe hearing loss or visual impairment
• Acute brain injury
• Intracranial haemorrhage within one year before participation in the study
• Manifest psychiatric disease
• Known illicit substance abuse
• Acute intoxication
• For women: Pregnancy or positive pregnancy test within the preoperative screening
• Homeless or other circumstances, where the patient would not be reachable by telephone or postal services for the 3-months follow up
• Participation in another interventional clinical trial according to the German Drug Law at time of inclusion and during the trial
• Acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite vasopressors or optimal preload)
• AV-conduction-block II or III (unless pacemaker installed)
• Severe bradycardia (heart-rate < 50 bpm, preoperative, permanent)
• Spinal cord injury with known autonomic dysregulation
• Preoperative acute cerebrovascular event with neurologic residues
• Liver insufficiency (Child C cirrhosis, MELD Score > 17)
• Application of Remifentanil during the operation
• Deep sedation (RASS, -4 to -5)
• Administration of Clonidine during administration of the study drug
• Additional administration of Dexmedetomidine within 3 months after study inclusion

Control Group:

Inclusion criteria

• Patients aged ≥ 60 years of European descent (Caucasian)
• Male or female patients with ASA II+III
• ASA II+III-patients, for which no operation is planned within the next year
• No operation in the last half year before study inclusion
• Offered patient information and written informed consent

Exclusion criteria

• Minimal mental status examination (MMSE) < 24
• Missing informed consent for saving and hand out pseudonymous data
• Neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing
• Anacusis or Hypoacusis, which limits the conduction of the neurocognitive testing
• Taking psychothropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis and other substances, which limit the conduction of the neurocognitive testing