Delirium Clinical Trial
Official title:
Decreasing the Incidence of Delirium After Cardiac Surgery
In critically ill surgical patients, delirium (confusion and disorientation) is extremely common and is associated with longer hospital length of stay, mortality, cost, and long term cognitive impairment. The goal of the study is to establish whether benzodiazepines (a sedative, anti-anxiety drug) should be used as part of standard of care or be eliminated by comparing the chances of delirium in cardiac surgery patients between two groups: a group that receives benzodiazepines during surgery versus a group that does not receive benzodiazepines during surgery. Benzodiazepines have historically been used in cardiac anesthesia to decrease the risk of anesthesia awareness. The current standard of care is to keep the patient on inhaled anesthesia throughout the surgery which eliminates the need for intraoperative use of benzodiazepines. Benzodiazepines are still used based on practitioner preference. Findings of this study will allow all anesthesiologists to make more informed decisions about what level of care our patients need.
In critically ill surgical patients, delirium is extremely common and is associated with
longer hospital length of stay, mortality, cost, and long term cognitive impairment.
Benzodiazepine usage is common in anesthetic practice, and ICU literature demonstrates that
limiting post-operative benzodiazepines decreases the incidence of delirium. However, the
avoidance of preoperative and intraoperative benzodiazepines during cardiac surgery has not
been studied in terms of its effect on delirium. The goal of the study is establish whether
benzodiazepines should be used as part of standard of care or be eliminated by comparing the
incidence of delirium in cardiac surgical patients when randomized to a group that receives
benzodiazepines versus a group that does not receive benzodiazepines.
Potential subjects will be identified and recruited the day before surgery by primary
investigators. Patients undergoing coronary artery bypass grafting or single valve procedures
that consent to participate will be enrolled in the study. These patients may be consented
during the pre-operative period. Patients will be informed that whether they enroll in the
study or not, they will be receiving standard clinical care. Only subjects meeting all
inclusion criteria and requirements for continuation in the study will be consented.
Patient will be randomized by age (age is a predictor of delirium) to 3 groups:
- >80 years of age;
- 70-80 years of age;
- < 70 years of age.
Within these 3 groups, patients will be randomized to receive benzodiazepines during cardiac
surgery or not. The anesthesiologist in the operating room will not be blinded to the group;
however, the intensive care physician evaluating for delirium will be blinded to the
treatment groups.
Benzodiazepine group:
1. Premedication 0.02mg/kg-0.1mg/kg of midazolam;
2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and
10-30mcg/kg of fentanyl;
3. Postoperative 10-100mcg/kg/min of propofol
Non-benzodiazepine group:
1. Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl;
2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and
10-30mcg/kg of fentanyl;
3. Postoperative 10-100mcg/kg/min of propofol
Delirium can now be reliably diagnosed by non-psychiatrists in critically ill patients in
less than 2 minutes through the use of validated monitoring instruments such as the Confusion
Assessment Method for the ICU (CAM-ICU).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
Recruiting |
NCT05891873 -
Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Recruiting |
NCT06194474 -
Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
|
||
Completed |
NCT03095417 -
Improving the Recovery and Outcome Every Day After the ICU
|
N/A | |
Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
Terminated |
NCT03337282 -
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
|
||
Not yet recruiting |
NCT04846023 -
Pediatric Delirium Screening in the PICU Via EEG
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Withdrawn |
NCT02673450 -
PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
|
||
Recruiting |
NCT03256500 -
Transcranial Direct Current Stimulation for the Treatment of Delirium
|
N/A | |
Completed |
NCT02890927 -
Geriatric-CO-mAnagement for Cardiology Patients in the Hospital
|
N/A | |
Not yet recruiting |
NCT02892968 -
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
|
N/A | |
Recruiting |
NCT03165539 -
Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
|
||
Completed |
NCT02518646 -
DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
|
N/A | |
Completed |
NCT02554253 -
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
|
Phase 2 | |
Recruiting |
NCT02305589 -
The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium
|
N/A | |
Completed |
NCT02628925 -
Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale
|
N/A |