Low Dose Dexmedetomidine and Delirium After Cardiac Surgery

Does LOW Dose DEXmedetomidine After Cardiopulmonary Bypass Separation Decrease the Incidence of DELirium: A Double-blind Randomized Placebocontrolled Study (LOWDEXDEL Study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002007-97-BE

Enrollment

270

Registered

2017-10-11

Start date

2017-12-07

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To find if Dexmedetomidine in cardiac surgery would have any neuroprotective effects by stimulating the alpha 2A-receptors and as such would decrease the incidence of postoperative delirium.

Interventions

Trade Name: DEXDOR Product Name: DEXDOR Pharmaceutical Form: Concentrate for solution for injection/infusion Trade Name: NaCL Product Name: NaCl Pharmaceutical Form: Pharmaceutical form of the place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing cardiac surgery with cardiopulmonary bypass Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: • Hepaticdysfunction (hepatic function tests 3 times the normal value) • Renal dysfunction requiring preoperative renal replacement • Preoperative delirium • Emergency surgery • Patients not speaking French

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of our study is to elucidate whether the administration of Dexmedetomidine at a low dose would decrease the incidence of PD in elderly patients undergoing cardiac surgery. The hypothesis is that Dexmedetomidine at low doses, by only stimulating the alpha2A adrenoceptors,would have neuroprotective affects ans as such decrease the incidence of PD. Dexmedetomidine would also have anti-inflammatory effects and effects on the quality of sleep, both of which mechanisms that would play a role in the pathophysiology of PD.;Secondary Objective: Not applicable;Primary end point(s): The incidence of delirium detected by means of CAM-ICU and CAM;Timepoint(s) of evaluation of this end point: During the time of the hospitalization	—

Measure

Time frame

Main Objective: The aim of our study is to elucidate whether the administration of Dexmedetomidine at a low dose would decrease the incidence of PD in elderly patients undergoing cardiac surgery. The hypothesis is that Dexmedetomidine at low doses, by only stimulating the alpha2A adrenoceptors,would have neuroprotective affects ans as such decrease the incidence of PD. Dexmedetomidine would also have anti-inflammatory effects and effects on the quality of sleep, both of which mechanisms that would play a role in the pathophysiology of PD.;Secondary Objective: Not applicable;Primary end point(s): The incidence of delirium detected by means of CAM-ICU and CAM;Timepoint(s) of evaluation of this end point: During the time of the hospitalization

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Secondary

Measure	Time frame
Secondary end point(s): Number of days spent in delirium;Timepoint(s) of evaluation of this end point: Measure the delirious state in days	—

Countries

Belgium

Contacts

Public ContactMona Momeni

Cliniques universitaires Saint-Luc

mona.momeni@uclouvain.be003227647029

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026