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

NCT ID: NCT02096068

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-07-31

Brief Summary

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.

Conditions

Delirium; Postoperative Cognitive Deficit (POCD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Dexmedetomidine (Dexdor®)

Intervention Type: DRUG

Dexmedetomidine (Dexdor 100 micrograms/ml concentrate for solution for infusion)

Control group

Application of placebo for a maximum of 48 hours

Group Type: PLACEBO_COMPARATOR

0.9% Sodium Chloride

Intervention Type: DRUG

Solution for infusion: Sodium Chloride : 9.0 g/l; Each ml contains 9 mg sodium chloride mmol/l : Na+ : 154. Cl-: 154.

POCD control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexmedetomidine (Dexdor®)

Dexmedetomidine (Dexdor 100 micrograms/ml concentrate for solution for infusion)

Intervention Type: DRUG

0.9% Sodium Chloride

Solution for infusion: Sodium Chloride : 9.0 g/l; Each ml contains 9 mg sodium chloride mmol/l : Na+ : 154. Cl-: 154.

Intervention Type: DRUG

Eligibility 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 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

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. 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:

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claudia Spies

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine CVK/CCM

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charité-University Medicine (Berlin, Germany)

Locations

Department of Anesthesiology and Operative Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 35543164 (View on PubMed)

Other Identifiers

Neuprodex

Identifier Type: -

Identifier Source: org_study_id