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

Primary Purpose

Intensive Care Unit Delirium

Status
Recruiting
Phase
Phase 3
Locations
Serbia
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Sponsored by
University of Novi Sad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intensive Care Unit Delirium focused on measuring open heart surgery, sedation, dexmedetomidine, postoperative delirium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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%. Exclusion Criteria: 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

Sites / Locations

  • Institute of Cardiovascular Diseases of VojvodinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexmedetomidine

Propofol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MV duration
Duration of mechanical ventilation
ICU length of stay
Total duration of stay in the intensive care unit
Hospital length of stay
Total duration of stay in hospital

Full Information

First Posted
April 26, 2023
Last Updated
May 8, 2023
Sponsor
University of Novi Sad
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1. Study Identification

Unique Protocol Identification Number
NCT05849597
Brief Title
Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery
Official Title
Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Novi Sad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study will include adult patients of both sexes scheduled for elective cardiac surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined). The patients included in the study will be randomized in 1:1 ratio using computer generated numbers into two groups. The first group of patients, upon arrival to the intensive care unit will be sedated with continuous dexmedetomidine infusion in doses 0.2-0.7 mcg/kg/h. Dexmedetomidine infusion will be discontinued before weaning from mechanical ventilation and extubation. The second group of patients, upon arrival to the intensive care unit will be sedated with continuous propofol infusion in doses 1-2 mg/kg/h. Propofol infusion will also be discontinued before weaning from mechanical ventilation and extubation. Sedation level will be assessed using Richmond Agitation and Sedation Scale (RASS) every two hours. Postoperative analgesia will be managed according to protocol (opioid analgesics, non-steroid anti-inflammatory drugs, paracetamol), with pain level assessment using visual analog scale (0 - no pain; 10 - unbearable pain). The following data will be registered: age, sex, body mass index (BMI), hemoglobin, heart rate, and LVEF. Among the postoperative parameters, the following will registered: duration of mechanical ventilation (in hours), extubation time, ICU and hospital length of stay (in days), postoperative hemoglobin, blood product transfusion rates, occurrence of atrial fibrillation and assessment of delirium. Assessment of delirium will be performed using the confusion assessment method for intensive care unit (CAM-ICU) every 12 hours during five postoperative days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Delirium
Keywords
open heart surgery, sedation, dexmedetomidine, postoperative delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Evaluate the effects of dexmedetomidine for sedation of patients in the intensive care unit after open heart surgery
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Compare the clinical outcomes of the experimental group with the standard of care, i.e. sedation with propofol
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of postoperative delirium
Description
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
Time Frame
5 days
Secondary Outcome Measure Information:
Title
MV duration
Description
Duration of mechanical ventilation
Time Frame
30 days
Title
ICU length of stay
Description
Total duration of stay in the intensive care unit
Time Frame
30 days
Title
Hospital length of stay
Description
Total duration of stay in hospital
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mihaela Preveden, MD
Phone
+381214805702
Email
mihaela.detki@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihaela Preveden, MD
Organizational Affiliation
Institute of Cardiovascular Diseases of Vojvodina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiovascular Diseases of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihaela Preveden, MD
Phone
+381214805702
Email
mihaela.detki@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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