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

Claudia Spies

Status and phase: Completed; Phase 4

Conditions: Delirium; Postoperative Cognitive Deficit (POCD)

Treatments: Drug: 0.9% Sodium Chloride; Drug: Dexmedetomidine (Dexdor®)

Study type: Interventional

Funder types: Other

Identifiers

NCT02096068

Neuprodex

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Study Group:

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 gastric or intestinal surgery of both Campus Charité Mitte and Campus Virchow - Klinikum, Charité - Universitätsmedizin Berlin
3. Offered patient information and written consent by the patient (according to German Drug Law § 40 (1) 3b)
4. Premedication only with benzodiazepines
5. Pain therapy during the operation with regional procedures and/or Sufentanil/Fentanyl
6. Anesthesia in cardio surgery according to Heart-Lung-Apparatus
7. Anesthesia with hypnotic agent Propofol
8. Pain therapy after operation according to S3-Guideline
9. Postoperative medication for anxiolysis only with benzodiazepines

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 - Universitätsmedizin Berlin CVK/CCM
5. Illiteracy
6. Inability to speak and/or read German
7. Minimal mental status examination (MMSE) < 24
8. Severe hearing loss or visual impairment
9. Acute brain injury
10. Intracranial haemorrhage within one year before participation in the study
11. Manifest psychiatric disease
12. Known illicit substance abuse
13. Acute intoxication
14. For women: Pregnancy or positive pregnancy test within the preoperative screening
15. Homeless or other circumstances, where the patient would not be reachable by telephone or postal services for the 3-months follow up
16. Participation in another interventional clinical trial according to the German Drug Law at time of inclusion and during the trial
17. Acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite vasopressors or optimal preload)
18. AV-conduction-block II or III (unless pacemaker installed)
19. Severe bradycardia (heart-rate < 50 bpm, preoperative, permanent)
20. Spinal cord injury with known autonomic dysregulation
21. Preoperative acute cerebrovascular event with neurologic residues
22. Liver insufficiency (Child C cirrhosis, MELD Score > 17)
23. Application of Remifentanil during the operation
24. Deep sedation (RASS, -4 to -5)
25. Administration of Clonidine during administration of the study drug
26. Additional administration of Dexmedetomidine within 3 months after study inclusion

Control Group:

Inclusion Criteria:

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

Exclusion Criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 3 patient groups, including a placebo group

Study group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine (Dexdor®)

Control group

Placebo Comparator group

Description:

Application of placebo for a maximum of 48 hours

Treatment:

Drug: 0.9% Sodium Chloride

POCD control group

No Intervention group

Description:

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.