Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery

NCT05849597 | Recruiting Phase 3

• 1 other identifier: 612-1/1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, single blinded, controlled clinical trial designed to compare the clinical effects of sedation with dexmedetomidine versus propofol in patients undergoing cardiac surgery.

Conditions

Intensive Care Unit Delirium

Keywords

open heart surgery; sedation; dexmedetomidine; postoperative delirium

Outcome Measures

Primary Outcomes (1)

• Occurrence of postoperative delirium

  Assessment of delirium will be performed using the confusion assessment method for intensive care unit (CAM-ICU) at any time in the first five days after surgery

  5 days

Secondary Outcomes (3)

• MV duration

  30 days

• ICU length of stay

  30 days

• Hospital length of stay

  30 days

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Evaluate the effects of dexmedetomidine for sedation of patients in the intensive care unit after open heart surgery

Drug: Dexmedetomidine

Propofol

ACTIVE COMPARATOR

Compare the clinical outcomes of the experimental group with the standard of care, i.e. sedation with propofol

Drug: Propofol

Interventions

Dexmedetomidine DRUG

Upon arrival to the intensive care unit after open heart surgery, the patients will be sedated with continuous dexmedetomidine infusion in doses 0.2-0.7 mcg/kg/h.

Dexmedetomidine

Propofol DRUG

Upon arrival to the intensive care unit after open heart surgery, the patients will be sedated with continuous propofol infusion in doses 1-2 mg/kg/h.

Propofol

Eligibility Criteria

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

You may qualify if:

• patients undergoing open heart surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined)
• left ventricular ejection fraction (LVEF) \>40%.

You may not qualify if:

• preoperative atrial fibrillation
• previous history of interventionally treated arrhythmias
• second and third degree atrioventricular block
• bradycardia with heart rate ≤50/min
• pacemaker
• renal or hepatic insufficiency
• emergency procedures
• history of serious mental illness, delirium, and severe dementia

Sponsors & Collaborators

• University of Novi Sad: lead

Study Sites (1)

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, 21204, Serbia

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mihaela Preveden, MD

  Institute of Cardiovascular Diseases of Vojvodina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihaela Preveden, MD

CONTACT

+381214805702; mihaela.detki@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 9, 2023
• Study Start: March 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)