Decreasing the Incidence of Delirium After Cardiac Surgery
| Status: | Withdrawn |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/14/2018 |
| Start Date: | August 2017 |
| End Date: | August 2017 |
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.
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).
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).
Inclusion Criteria:
- Adult patients' undergoing coronary artery bypass grafting or single valve procedures.
Exclusion Criteria:
- Patients who have baseline cognitive dysfunction,
- Patients with hearing problems,
- Patients currently on benzodiazepines
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Jacques Neelankavil, M.D.
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