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

NCT02096068 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2019-09-25

No results posted yet for this study

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)

Interventions

DRUG

Dexmedetomidine (Dexdor®)

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

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.

Sponsors & Collaborators

  • Claudia Spies

    lead OTHER

Principal Investigators

  • Claudia Spies, MD, Prof. · Charité-University Medicine (Berlin, Germany)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-03-17
Completion
2018-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096068 on ClinicalTrials.gov