Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The drug Dexmedetomidine will be investigated in 72 patients (men and women) undergoing elective cardiac or abdominal surgery. The study medication will be administered perioperatively by intravenous infusion continuously (at the longest 48 h) to prevent/reduce the rate of Delirium and the incidence of postoperative cognitive deficit (POCD).
A non-surgical control group of 15 ASA II/III- patients from Berlin and surrounding area is collected for measuring the learning experience during the cognitive testings. The participants are matched on age, education, and gender to the study patients.
Cognitive testings are performed in patients of the study group (n= 72) and the control group (n= 15) to evaluate deficits in their cognitive areas (POCD (Postoperative cognitive deficit)) at three different time points up to three months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Application of Dexmedetomidine (Dexdor®) perioperatively for a maximum of 48 hours Dosing Scheme: during operation and mechanical ventilation: 0,7μg/kgABW/h; recovery time until extubation: 0,4μg/kgABW/h; after extubation: 0,2-1,4μg/kgABW/h |
|
| Control group | Placebo Comparator | Application of placebo for a maximum of 48 hours |
|
| POCD control group | No Intervention | A non-surgical control group of 15 ASA II/III- patients is collected for measuring the learning experience during the cognitive testings. The participants are matched on age, education, and gender to the study patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine (Dexdor®) | Drug | Dexmedetomidine (Dexdor 100 micrograms/ml concentrate for solution for infusion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | Incidence of postoperative delirium measured with the Confusion Assessment Method for the ICU (CAM-ICU) or the Confusion Assessment Method (CAM) | Until the 5th postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subsyndromal delirium and severity of postoperative delirium | Incidence of Subsyndromal Delirium (SSD) and severity of postoperative Delirium measured with the Intensive Care Delirium Screening Checklist (ICDSC) | Until the 14th postoperative day/discharge |
| Duration of delirium in the intensive care unit |
Not provided
Study Group:
Inclusion Criteria:
Exclusion Criteria:
Control Group:
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD, Prof. | Charité-University Medicine (Berlin, Germany) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Operative Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35543164 | Derived | Singh A, Brenna CTA, Broad J, Kaustov L, Choi S. The Effects of Dexmedetomidine on Perioperative Neurocognitive Outcomes After Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2022 May 1;275(5):864-871. doi: 10.1097/SLA.0000000000005196. Epub 2021 Aug 27. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 0.9% Sodium Chloride | Drug | Solution for infusion: Sodium Chloride : 9.0 g/l; Each ml contains 9 mg sodium chloride mmol/l : Na+ : 154. Cl-: 154. |
|
Duration of intensive care unit-delirium measured with the Confusion Assessment Method for the ICU (CAM-ICU) and the Intensive Care Delirium Screening Checklist (ICDSC) |
| Until the 14th postoperative day/discharge |
| Severity of anxiety | Severity of anxiety measured with the Faces Anxiety Scale (FAS) | Up to three months |
| Management of sedation | Management of sedation measured by the Richmond Agitation Sedation Scale (RASS) | Until the 5th postoperative day |
| Management of vigilance | Management of Vigilance measured by Glasgow Coma Scale (GCS) | Until the 5th postoperative day |
| Management of analgesia and pain levels | Management of analgesia and pain levels measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI) | Up to three months |
| Relevant medication | Until the 5th postoperative day |
| Severity of illness | Severity of illness measured by Sequential Organ Failure Assessment (SOFA-Score), Simplified Acute Physiology Score (SAPS II) and the Acute Physiology and Chronic Health Evaluation (APACHE II) | Up to 14 postoperative days |
| Mechanical ventilation/weaning failure | Until the 5th postoperative day |
| Intraoperative cerebral oxymetry | At time of surgery |
| Processive Electroencephalography and Electromyography (EEG/EMG) -Data (SedLine®) | At time of surgery |
| Determination of blood levels | Complete blood count performance (Sysmex®) and acetylcholinesterase-analysis | Change from baseline complete blood count performance (Sysmex®) and acetylcholinesterase-analysis at third postoperative day |
| Cortisol-analysis | Up to three months |
| Organ dysfunctions | Up to three months |
| Infections | Infections according to surgical site infections (SSI) and according to the US Centers for Disease Control and Preventions (CDC). | Up to three months |
| ICU length of stay | Participants will be followed for the duration of intensive care stay, an expected average of 2 days |
| Hospital length of stay | Discharge criteria have to be met according to Post Anaesthetic Discharge Scoring System (PADSS) for monitoring patients discharge. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Quality of life | Quality of life is measured by EQ-5D (EuroQol Group), a measure generating a single index value for health status with considerable potential for use in health care evaluation | Up to three months |
| Incidence of postoperative cognitive dysfunction | Incidence of postoperative cognitive dysfunction (POCD) is measured by Cambridge Neuropsychological Test Automated Battery (CANTAB®) and Mini Mental State Examination (MMSE) including subjective memory feeling (Item 10 of the Geriatric Depression Scale (for already included patients the retrospective follow up by telephone interview)), including limitations in daily activities (EQ-5D) | Up to three months |
| Mortality | Up to three months |
| Sleep quality | Up to three months |
| Photomotor reflex | At time of surgery |
| Changes of hemodynamic parameters in the intraoperative transesophageal echocardiography | Hemodynamic aparemters are measured in patients for elective CABG surgery | At time of surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |