Coronary Artery Disease, Delirium
Conditions
Keywords
Cardiopulmonary Bypass, Cardiac Surgery, analgesics
Brief summary
The main purpose of this study is to determine whether a rational strategy of EEG guided multimodal general anesthesia using target specific sedative and analgesics could result in enhanced recovery after anesthesia and surgery, decrease in postoperative delirium, and decrease in long term postoperative cognitive dysfunction up to 6 months following cardiac surgery.
Detailed description
The main purpose of this study is to determine whether a rational strategy of EEG guided multimodal general anesthesia using target specific sedative and analgesics could result in enhanced recovery after anesthesia and surgery, decrease in postoperative delirium, and decrease in long term postoperative cognitive dysfunction up to 6 months following cardiac surgery. Specific Aim 1: The feasibility of implementing multimodal general anesthesia strategy in the Operating Rooms (OR) Specific Aim 2: The feasibility of implementing EEG guided sedation until extubation in the Intensive Care Unit (ICU) Specific Aim 3: The enhancement of recovery after surgery (shorter ventilation time, ICU stay, hospital length of stay) Specific Aim 4: To estimate the effect size of decrease in postoperative day (POD) and postoperative cognitive dysfunction (POCD) to power future large randomized trials
Interventions
DRUGPropofol
Intraoperative infusion
DRUGSevoflurane
Intraoperative inhaled as needed
DRUGDexmedetomidine
Intraoperative infusion
DRUGRocuronium
Intraoperative intermittent bolus
DRUGRopivacaine
Intraoperative bilateral PIFB block with 20 mL of 0.25% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision
DRUGKetamine
Intraoperative infusion
DRUGRemifentanil
Intraoperative infusion
DEVICEEEG monitoring
Perioperative monitoring
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
2 roll-in patients followed by 20 patients in the interventional model.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 60 years 2. Undergoing any of the following types of surgery with cardiopulmonary bypass limited to coronary artery bypass surgery (CABG), CABG+valve surgeries and isolated valve surgeries.
Exclusion criteria
1. Preoperative left ventricular ejection fraction (LVEF) \<30% 2. Emergent surgery 3. Non-English speaking 4. Cognitive impairment as defined by total MoCA score \< 10 5. Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI 6. Significant visual impairment 7. Chronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year) 8. Hypersensitivity to any of the study medications 9. Known history of alcohol (\> 2 drinks per day) or drug abuse Active (in the past year) history of alcohol abuse (≥5 drinks/day for men or ≥4 drinks/day for women) as determined by reviewing medical record and history given by the patient 10. Liver dysfunction (liver enzymes \> 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delirium | Participants will be followed for the duration of the hospital stay, an average of 5 days | Incidence of delirium will be analyzed in patients treated with the multi-modal approach. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM)Assessment Method (CAM) algorithm postoperatively until discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | On the day of discharge, an average of 6 days | MoCA scores (total possible score is 30 points; a score of 26 or above is considered normal) at discharge will be reported in order to assess the occurrence of postoperative cognitive decline. Study staff trained in administering the assessments will collect the data. |
| Pain scores | At 4-8 hourly intervals every day until discharge, an average of 6 days | Patient reported pain scores on a scale from 0-10 (0 no pain,10 extreme pain), until discharge for the index admission. |
| Total opioid and supplemental analgesic consumption | 48 hours, post-operative | The total opioid dosage and supplemental analgesic dosage received in the first 48 hours postoperatively will be abstracted from the medical record. |
| Time to extubation | Time of ICU admission until time of extubation in ICU, an average of 6 hours | Time to extubation will be noted from ICU data |
| ICU/hospital length of stay | Time of stay in the hospital until discharge to floor or rehab, an average of 5 days | Their stay in the hospital for the index admission |
| In-hospital complications | 7 days post-op on an average | stroke, myocardial infarction (MI), acute kidney injury, pneumonia, reintubation, congestive heart failure, sepsis, reopening of sternum and all-cause mortality |
| Follow up incidence of delirium | Patients will be assessed for delirium at 1 month and 6 months following the date of surgery | The follow up incidence of delirium will be analyzed at 1 month and 6 months after discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the MoCA/t-MoCA. |
| ICU | Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days | Total duration of stay in ICU for the index admission |
Countries
United States
Outcome results
None listed