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DeliriumPhase 4NCT02096068

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

A Phase 4 study testing Dexmedetomidine (Dexdor®) and 0.9% Sodium Chloride in people with Delirium and Postoperative Cognitive Deficit (POCD), run by Claudia Spies at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Dexmedetomidine (Dexdor®) and 0.9% Sodium Chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteGermany
Study dates
Jul 2014to Jul 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Anesthesia with hypnotic agent Propofol
  • Pain therapy after operation according to S3-Guideline
  • Postoperative medication for anxiolysis only with benzodiazepines
  • 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

Who cannot join

  • 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
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  • 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:
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Berlin, 13353

Other trials in Germany

About this study

Official title: Neuroprotection With Dexmedetomidine in Patients Undergoing Elective Cardiac or Abdominal Surgery (NEUPRODEX)

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.

Being tested
Dexmedetomidine (Dexdor®), 0.9% Sodium Chloride
Keywords
Neuroprotection
Medical subject headings
Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine (Dexdor®)Drug

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

  • 0.9% Sodium ChlorideDrug

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

Study groups in NCT02096068
Study groupRoleWhat they receive
Study groupExperimentalApplication 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
Receives: Drug: Dexmedetomidine (Dexdor®)
Control groupPlacebo comparatorApplication of placebo for a maximum of 48 hours
Receives: Drug: 0.9% Sodium Chloride
POCD control groupNo interventionA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Until the 5th postoperative day

Secondary outcomes (23)

  1. 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)

    Measured: Until the 14th postoperative day/discharge

  2. Duration of delirium in the intensive care unit

    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)

    Measured: Until the 14th postoperative day/discharge

  3. Severity of anxiety

    Severity of anxiety measured with the Faces Anxiety Scale (FAS)

    Measured: Up to three months

  4. Management of sedation

    Management of sedation measured by the Richmond Agitation Sedation Scale (RASS)

    Measured: Until the 5th postoperative day

  5. Management of vigilance

    Management of Vigilance measured by Glasgow Coma Scale (GCS)

    Measured: Until the 5th postoperative day

  6. 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)

    Measured: Up to three months

  7. Relevant medication

    Measured: Until the 5th postoperative day

  8. 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)

    Measured: Up to 14 postoperative days

  9. Mechanical ventilation/weaning failure

    Measured: Until the 5th postoperative day

  10. Intraoperative cerebral oxymetry

    Measured: At time of surgery

  11. Processive Electroencephalography and Electromyography (EEG/EMG) -Data (SedLine®)

    Measured: At time of surgery

  12. Determination of blood levels

    Complete blood count performance (Sysmex®) and acetylcholinesterase-analysis

    Measured: Change from baseline complete blood count performance (Sysmex®) and acetylcholinesterase-analysis at third postoperative day

  13. Cortisol-analysis

    Measured: Up to three months

  14. Organ dysfunctions

    Measured: Up to three months

  15. Infections

    Infections according to surgical site infections (SSI) and according to the US Centers for Disease Control and Preventions (CDC).

    Measured: Up to three months

  16. ICU length of stay

    Measured: Participants will be followed for the duration of intensive care stay, an expected average of 2 days

  17. Hospital length of stay

    Discharge criteria have to be met according to Post Anaesthetic Discharge Scoring System (PADSS) for monitoring patients discharge.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  18. 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

    Measured: Up to three months

  19. 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)

    Measured: Up to three months

  20. Mortality

    Measured: Up to three months

  21. Sleep quality

    Measured: Up to three months

  22. Photomotor reflex

    Measured: At time of surgery

  23. Changes of hemodynamic parameters in the intraoperative transesophageal echocardiography

    Hemodynamic aparemters are measured in patients for elective CABG surgery

    Measured: At time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2014 (estimated)
  2. Study startJul 2014
  3. Primary completion17 Mar 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02096068
Sponsor's protocol ID
Neuprodex
Status last verified
Sep 2019
First submitted
21 Mar 2014
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35543164

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine (Dexdor®) and 0.9% Sodium Chloride in people with Delirium and Postoperative Cognitive Deficit (POCD), run by Claudia Spies at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative delirium (time frame: Until the 5th postoperative day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02096068, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.

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