The drug Dexmedetomidine will be investigated in patients (men and women) undergoing elective cardiac or abdominal surgery. The study medication will be administered perioperatively by intravenous infusion continously (at the longest 48 h) to prevent/reduce the rate of Delirium and the incidence of POCD.
Conditions
Interventions
Trade Name: Dexdor 100 Microgramm
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged = 60 years 2.Male and female patients undergoing elective cardiac (elective CABG-surgery without valve surgery with left ventricular ejection fraction = 30%) or pancreatic or hepatic or intestinal or gastric surgery of both Campus Charité Mitte and Campus Virchow - Klinikum, Charité – University Medicine Berlin 3.Offered patient information and written consent by the patient (according to AMG § 40 (1) 3b) 4.Premedication only with benzodiazepines 5.Paintherapy during the operation with regional procedures and/or Sufentanil/Fentanyl 6.Anesthesia in cardioasurgery according to Heart-Lung-Apparatus 7.Anesthesia with hypnoticum Propofol 8.Paintherapy after operation according to S3-Guideline 9.Postoperative medication for anxiolysis only with benzodiazepines 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 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1.Known drug intolerance/allergy: dexmedetomidine or to other ingredients 2.Lacking willingness to save and hand out pseudonymised data within the clinical trial 3.Accommodation in an institution due to an official or judicial order (according to AMG §40 (1) 4) 4. Employee of the Charité - University - Medicine Berlin CVK/CCM 5. Illiteracy 6. Inability to speak and/or read German 7. Minimal mental status examination (MMSE) 17) 23. Aplication of Remifentanil during the operation 24. Postoperatively planned deep sedation (RASS, -4 to -5) 25. Administration of Clonidin during administration of the study drug 26. Additional administration of Dexmedetomidine within 3 months after study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Incidence of postoperative delirium measured with the Confusion Assessment Method for the ICU (CAM-ICU)“or the „Confusion Assessment Method (CAM) and/or Chart Review and/or DSM V/ICD-10 “;Secondary Objective: 1.Incidence of Subsyndromal Delirium (SSD) 2.Severity of Delirium 3. Incidence of POCD incl. subjective Memory - feeling 4.Severity of anxiety (Faces Anxiety Scale)5.Management of sedation (RASS –Score)6.Management of Vigilance Glasgow Coma Scale 7.Management of analgesia and pain levels: (NRS-V or FPS-R or BPS or BPS-NI) 8.Relevant medication 9.Severity of illness (SAPS II, APACHE II, SOFA) 10.Mechanical ventilation/weaning failure 11. Cerebral oximetry 12. Processive EEG/EMG-Data(SedLine®) 13.Complete blood count, AChE-analysis 14.Cortisol-analysis 15.Organ dysfunctions 16.Infections 17.LOS-ICU 18.LOS-hospital 19.Quality of life (EuroQuol 5D (EQ-5D-Instrument)) 20.Incidence of postop. ve cognitive dysfunction (POCD) (CANTAB®, MMS) 21.Mortality 22. Sleep quality 23. Changes of hemodynamic parameters in the intraoperative transesophageal echocardiography 24. Photomotor Reflex ;Primary end point(s): Incidence of postoperative delirium measured with the Confusion Assessment Method for the ICU (CAM-ICU)“or the „Confusion Assessment Method (CAM) and/or Chart Review and/or DSM V/ICD-10 “; Timepoint(s) of evaluation of this end point: Measured until the 5th postoperative day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Incidence of Subsyndromal Delirium (SSD) 2.Severity of Delirium 3. Incidence of POCD (Cambridge Neuropsychological Automated Test Battery CANTAB®, Minimal Mental Status Examination MMSE) including subjective Memory - feeling (Item 10 of the Geriatric Depression Scale, including limitation in usual activities (EQ-5D)) 4.Severity of anxiety (Faces Anxiety Scale FAS)5.Management of sedation (RASS –Score)6.Management of Vigilance Glasgow Coma Scale (GCS) 7.Management of analgesia and pain levels: (NRS-V or FPS-R or BPS or BPS-NI) 8.Relevant medication 9.Severity of illness (SAPS II, APACHE II, SOFA) 10.Mechanical ventilation/weaning failure 11. Cerebral Oximetry 12. Processive EEG/EMG-Data(SedLine®) 13.Complete blood count (Sysmex Parameter), AChE-analysis 14.Cortisol-analysis 15.Organ dysfunctions 16.Infections (CDC), (SSI)) 17.LOS-ICU 18.LOS-hospital (time that discharge criteria were met: PADSS) 19.Quality of life (EuroQuol 5D (EQ-5D-Instrument)) 20.Incidence of postoperative cognitive dysfunction (POCD) (CANTAB®, MMS) 21.Mortality (3-month-mortality) 22. Sleep quality 23. Changes of hemodynamic parameters in the intraoperative transesophageal echocardiography (size and function of left and right ventricle; diastolic function; cardiac responsiveness to volume; heart valves and their function] 24. Photomotor Reflex ; Timepoint(s) of evaluation of this end point: Measured: 1-2and 5-6 and 8-10 until the 5th postoperative day 11-12 intraoperatively until first postoperative day 13 preoperatively and until the 3rd postoperative day 14 preoperatively and until the 3rd postoperative day, at discharge and after 3 months 17-18 until the end of hospital stay 3,4 and 7 and 15-16 and 19-22 until 3 months 23 intraoperatively; 24 preoperatively at the day of operation and at discharge | — |
Countries
Germany
Contacts
Public ContactUniv.-Prof. Dr. C. Spies
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)
Outcome results
None listed