Trial Outcomes & Findings for Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing carDiac surgERies (NCT NCT05279898)

Last Updated: 2025-11-26

Results Overview

Plasma interleukin-6 (IL-6) levels will be measured at baseline, postoperative day 1, and postoperative day 2. The change in IL-6 concentration from baseline to each postoperative time point will be calculated and compared between the study groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

Baseline, postoperative day 1, and postoperative day 2

Results posted on

2025-11-26

Participant Flow

Participants undergoing elective cardiac surgery were recruited from a tertiary academic hospital between February 28, 2023, and December 31, 2024, for a randomized trial comparing EEG-guided multimodal general anesthesia with standard care. Recruitment occurred in preoperative clinics, inpatient wards, and surgical units.

There were no washout, run-in, or lead-in phases. All enrolled participants were randomized in a 1:1 ratio to either the EEG-guided multimodal general anesthesia (MMGA) group or the standard care group without pre-assignment exclusions.

Participant milestones

Participant milestones
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Overall Study STARTED	35	35
Overall Study Surgery	33	34
Overall Study 1 month Follow-up	19	23
Overall Study 6 month Follow-up	18	21
Overall Study COMPLETED	33	34
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	1

Baseline Characteristics

One participant's baseline information is missing in the intervention group

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, postoperative day 1, and postoperative day 2

Population: The number of participants analyzed at each time point differs from the number originally assigned due to missing or inadequate biospecimen samples for IL-6 and NFL measurements at baseline and postoperative days 1 and 2. Participants without valid samples at a given time point were excluded from that specific analysis.

Outcome measures

Outcome measures
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=34 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=32 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Increase in Plasma IL-6 Levels IL-6 - Baseline	15 pg/mL Standard Deviation 28.5	29.5 pg/mL Standard Deviation 79.9
Increase in Plasma IL-6 Levels Il-6 - POD1	80.5 pg/mL Standard Deviation 65.4	97.7 pg/mL Standard Deviation 93.5
Increase in Plasma IL-6 Levels IL-6 - POD2	115.7 pg/mL Standard Deviation 64.1	164 pg/mL Standard Deviation 108.7

PRIMARY outcome

Timeframe: Baseline, postoperative day 1, and postoperative day 2

Plasma neurofilament light (NfL) levels will be measured at baseline, postoperative day 1, and postoperative day 2. The change in NfL concentration from baseline to each postoperative time point will be calculated and compared between the study groups.

Outcome measures

Outcome measures
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=34 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=32 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Increase in Plasma Neurofilament Light Levels NFL - Baseline	40.9 pg/mL Standard Deviation 37.1	28.6 pg/mL Standard Deviation 37.4
Increase in Plasma Neurofilament Light Levels NFL - POD1	37.4 pg/mL Standard Deviation 39.5	25.8 pg/mL Standard Deviation 23.2
Increase in Plasma Neurofilament Light Levels NFL - POD2	56.8 pg/mL Standard Deviation 49.3	52.8 pg/mL Standard Deviation 46.5

SECONDARY outcome

Timeframe: From end of surgery to 48 hours postoperatively

Population: 2 subjects in intervention group and 1 subject in control group withdrew from study after the consent before the start of study procedure

Total opioid consumption during the first 48 postoperative hours will be calculated by summing all opioid doses administered in any route and converting to intravenous morphine milligram equivalents (MME) for standardization. The cumulative 48-hour opioid dose will be compared between groups.

Outcome measures

Outcome measures
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=33 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=34 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Opioid Consumption	132.42 Morphine Milligram Equivalents (MME) Standard Deviation 77.05	126.93 Morphine Milligram Equivalents (MME) Standard Deviation 58.12

SECONDARY outcome

Timeframe: From end of surgery to 48 hours postoperatively

Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), a validated 11-point scale that measures patient-reported pain intensity from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Scores will be obtained by nursing staff every 4-8 hours from electronic medical records, and the average 48-hour postoperative pain score will be compared between groups.

Outcome measures

Outcome measures
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=33 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=34 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Pain Scores	4.33 Scores on a scale Standard Deviation 1.56	4.72 Scores on a scale Standard Deviation 1.69

SECONDARY outcome

Timeframe: intraoperative period, from anesthetic induction until the end of surgery

Population: 5 subjects from the intervention group and 4 subjects in control group are removed from analysis due to artifacts in EEG data

Duration of burst suppression was extracted and quantified from the intraoperative EEG record and compared between the MMGA and control groups.

Outcome measures

Outcome measures
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=28 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=30 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Burst Suppression	4.83 minutes Standard Deviation 3.47	1.68 minutes Standard Deviation 2.2

SECONDARY outcome

Timeframe: From postoperative day 1 until hospital discharge, an average of 4 days

Incidence of Postoperative Delirium (POD) will be compared between both groups: POD will be diagnosed by our trained research members based on the Confusion Assessment Method (CAM) algorithm postoperatively until discharge.

Outcome measures

Outcome measures
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=33 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=33 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Postoperative Delirium	8 Participants with delirium 2.6	9 Participants with delirium 2.78

SECONDARY outcome

Timeframe: Patients will be assessed for cognitive function at 1 month and 6 months following the date of surgery

Population: Lost to follow-up

Postoperative cognitive function will be assessed at 1 and 6 months after surgery using the telephone version of the Montreal Cognitive Assessment (t-MoCA). The t-MoCA has a total score range of 0 to 22, where higher scores indicate better cognitive function.

Outcome measures

Outcome measures
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=20 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=25 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Cognitive Function 1 month follow-up	18.421 scores on a scale Standard Deviation 2.631	18.174 scores on a scale Standard Deviation 2.855
Cognitive Function 6 month follow-up	18.100 scores on a scale Standard Deviation 2.075	18.960 scores on a scale Standard Deviation 1.767

SECONDARY outcome

Timeframe: Intraoperative period, from induction of anesthesia until transfer from the operating room

Population: 3 subjects change of consent status before surgery

Metrics of total vasopressor dose in norepinephrine equivalents (mcg/kg/min) will be collected from the intra-operative record and medical records to be quantified and compared.

Outcome measures

Outcome measures
Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=33 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=34 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
Hemodynamic Stability - Total Vasopressor Dose	1109.425 norepinephrine equivalents (mcg/kg/min) Standard Deviation 2311.095	2358.042 norepinephrine equivalents (mcg/kg/min) Standard Deviation 4543.262

Adverse Events

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care/Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Balachundhar Subramaniam

Beth Israel Deaconess Medical Center

Phone: 617-278-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Multimodal General Anesthesia (MMGA Bundle) - EEG Guided n=34 Participants 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. Standard pain management protocol * IV Acetaminophen * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches	Standard of Care/Control n=35 Participants EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane 1. Standard pain management protocol * IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival * IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia * Other oral pain medications as per standard of care (Oxycodone, etc) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion	Total n=69 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 6 • n=34 Participants • One participant's baseline information is missing in the intervention group	71 years STANDARD_DEVIATION 7 • n=35 Participants • One participant's baseline information is missing in the intervention group	70.507 years STANDARD_DEVIATION 6.50 • n=69 Participants • One participant's baseline information is missing in the intervention group
Sex: Female, Male Female	5 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	8 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	13 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Sex: Female, Male Male	29 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	27 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	56 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	0 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	0 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Race (NIH/OMB) Asian	2 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	1 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	3 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	0 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	0 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Race (NIH/OMB) Black or African American	2 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	1 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	3 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Race (NIH/OMB) White	30 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	33 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	63 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Race (NIH/OMB) More than one race	0 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	0 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	0 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=34 Participants • One participant's baseline information is missing in the intervention group	0 Participants n=35 Participants • One participant's baseline information is missing in the intervention group	0 Participants n=69 Participants • One participant's baseline information is missing in the intervention group
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=34 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group	0 Participants n=34 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group	1 Participants n=68 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=34 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group	34 Participants n=34 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group	67 Participants n=68 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=34 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group	0 Participants n=34 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group	0 Participants n=68 Participants • One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group
Baseline plasma IL-6 and NFL Levels IL-6 - Baseline	15 pg/mL STANDARD_DEVIATION 28.5 • n=34 Participants • The number of participants analyzed at each time point differs from the number originally assigned due to missing or inadequate biospecimen samples for IL-6 and NFL measurements at baseline. Participants without valid samples at a given time point were excluded from that specific analysis.	29.5 pg/mL STANDARD_DEVIATION 79.9 • n=32 Participants • The number of participants analyzed at each time point differs from the number originally assigned due to missing or inadequate biospecimen samples for IL-6 and NFL measurements at baseline. Participants without valid samples at a given time point were excluded from that specific analysis.	22.03 pg/mL STANDARD_DEVIATION 59.15 • n=66 Participants • The number of participants analyzed at each time point differs from the number originally assigned due to missing or inadequate biospecimen samples for IL-6 and NFL measurements at baseline. Participants without valid samples at a given time point were excluded from that specific analysis.
Baseline plasma IL-6 and NFL Levels NFL Baseline	40.9 pg/mL STANDARD_DEVIATION 37.1 • n=34 Participants • The number of participants analyzed at each time point differs from the number originally assigned due to missing or inadequate biospecimen samples for IL-6 and NFL measurements at baseline. Participants without valid samples at a given time point were excluded from that specific analysis.	28.6 pg/mL STANDARD_DEVIATION 37.4 • n=32 Participants • The number of participants analyzed at each time point differs from the number originally assigned due to missing or inadequate biospecimen samples for IL-6 and NFL measurements at baseline. Participants without valid samples at a given time point were excluded from that specific analysis.	34.93 pg/mL STANDARD_DEVIATION 37.48 • n=66 Participants • The number of participants analyzed at each time point differs from the number originally assigned due to missing or inadequate biospecimen samples for IL-6 and NFL measurements at baseline. Participants without valid samples at a given time point were excluded from that specific analysis.