NCT03388541

Brief Summary

Delirium after cardiac surgery can occur in up to 50% of the patients and has been shown to be significantly associated with increased morbidity and mortality. Advanced age is a significant risk factor of delirium. Numerous studies have shown that sedation with high doses of Dexmedetomidine in the ICU reduces the incidence of postoperative delirium. On the other hand animal studies have shown neuroprotective effects of Dexmedetomidine by means of stimulating alpha2A-adrenoceptors. It is not clear whether the administration of a low dose 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

January 17, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

August 1, 2017

Last Update Submit

September 28, 2020

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • The incidence of delirium

    The incidence of delirium detected by means of CAM-ICU and CAM

    Through study completion, an average of 30 days

Secondary Outcomes (8)

  • Number of days spent in delirium

    Through study completion, an average of 30 days

  • ICU stay

    Through study completion, an average of 30 days

  • Total dose of analgesics

    Through study completion, an average of 30 days

  • Total dose of vasopressors

    Through study completion, an average of 30 days

  • Pace maker necessitation

    Through study completion, an average of 30 days

  • +3 more secondary outcomes

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine will be administered at 0.4ug/kg/h (5mL/h) starting at the closure of the chest and continued during 10h.

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

NaCl 0.9% will be administered at 5mL/h starting at the closure of the chest and continued during 10h.

Drug: Placebo

Interventions

DexmedetomidineDRUG

Dexmedetomidine will be started at 5mL/h while the patient is still in the operating room. The patient will be transferred to the intensive care unit with a sedative regimen based on propofol.

Dexmedetomidine
PlaceboDRUG

A continuous infusion of NaCL 0.9% will be started at 5mL/h while the patient is still in the operating room. The patient will be transferred to the intensive care unit with a sedative regimen based on propofol.

Placebo

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • Hepatic dysfunction (hepatic function tests 3 times the normal value)
  • Preoperative renal replacement therapy
  • Preoperative delirium
  • Emergency surgery not allowing neurologic evaluation by MMSE
  • Mini invasive cardiac surgery
  • Patients not speaking French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Related Publications (8)

  • Paris A, Mantz J, Tonner PH, Hein L, Brede M, Gressens P. The effects of dexmedetomidine on perinatal excitotoxic brain injury are mediated by the alpha2A-adrenoceptor subtype. Anesth Analg. 2006 Feb;102(2):456-61. doi: 10.1213/01.ane.0000194301.79118.e9.

    PMID: 16428542BACKGROUND

  • Maier C, Steinberg GK, Sun GH, Zhi GT, Maze M. Neuroprotection by the alpha 2-adrenoreceptor agonist dexmedetomidine in a focal model of cerebral ischemia. Anesthesiology. 1993 Aug;79(2):306-12. doi: 10.1097/00000542-199308000-00016.

    PMID: 8102042BACKGROUND

  • Jiang L, Hu M, Lu Y, Cao Y, Chang Y, Dai Z. The protective effects of dexmedetomidine on ischemic brain injury: A meta-analysis. J Clin Anesth. 2017 Aug;40:25-32. doi: 10.1016/j.jclinane.2017.04.003. Epub 2017 Apr 17.

    PMID: 28625441BACKGROUND

  • Tasdogan M, Memis D, Sut N, Yuksel M. Results of a pilot study on the effects of propofol and dexmedetomidine on inflammatory responses and intraabdominal pressure in severe sepsis. J Clin Anesth. 2009 Sep;21(6):394-400. doi: 10.1016/j.jclinane.2008.10.010.

    PMID: 19833271BACKGROUND

  • Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.

    PMID: 27542303BACKGROUND

  • Shehabi Y, Grant P, Wolfenden H, Hammond N, Bass F, Campbell M, Chen J. Prevalence of delirium with dexmedetomidine compared with morphine based therapy after cardiac surgery: a randomized controlled trial (DEXmedetomidine COmpared to Morphine-DEXCOM Study). Anesthesiology. 2009 Nov;111(5):1075-84. doi: 10.1097/ALN.0b013e3181b6a783.

    PMID: 19786862BACKGROUND

  • Djaiani G, Silverton N, Fedorko L, Carroll J, Styra R, Rao V, Katznelson R. Dexmedetomidine versus Propofol Sedation Reduces Delirium after Cardiac Surgery: A Randomized Controlled Trial. Anesthesiology. 2016 Feb;124(2):362-8. doi: 10.1097/ALN.0000000000000951.

    PMID: 26575144BACKGROUND

  • Momeni M, Khalifa C, Lemaire G, Watremez C, Tircoveanu R, Van Dyck M, Kahn D, Rosal Martins M, Mastrobuoni S, De Kerchove L, Zango SH, Jacquet LM. Propofol plus low-dose dexmedetomidine infusion and postoperative delirium in older patients undergoing cardiac surgery. Br J Anaesth. 2021 Mar;126(3):665-673. doi: 10.1016/j.bja.2020.10.041. Epub 2020 Dec 24.

    PMID: 33358336DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mona Momeni, MD,PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2017

First Posted

January 3, 2018

Study Start

January 17, 2018

Primary Completion

August 12, 2019

Study Completion

August 12, 2019

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)