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

NCT02096068 | Completed Phase 4

• 1 other identifier: Neuprodex
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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)

Keywords

Neuroprotection

Outcome Measures

Primary Outcomes (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)

  Until the 5th postoperative day

Secondary Outcomes (23)

• Incidence of subsyndromal delirium and severity of postoperative delirium

  Until the 14th postoperative day/discharge

• Duration of delirium in the intensive care unit

  Until the 14th postoperative day/discharge

• Severity of anxiety

  Up to three months

• Management of sedation

  Until the 5th postoperative day

• Management of vigilance

  Until the 5th postoperative day

Study Arms (3)

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

Drug: Dexmedetomidine (Dexdor®)

Control group

PLACEBO COMPARATOR

Application of placebo for a maximum of 48 hours

Drug: 0.9% Sodium Chloride

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.

Interventions

Dexmedetomidine (Dexdor®) DRUG

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

Study group

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.

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 35543164 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Claudia Spies, MD, Prof.

  Charité-University Medicine (Berlin, Germany)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine CVK/CCM

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: July 1, 2014
• Primary Completion: March 17, 2018
• Study Completion: July 1, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

DE (1)