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In the PATHFINDER 2 trial, the study investigators will test the intraoperative EEG-guided multimodal general anesthesia (MMGA) management strategy in combination with a postoperative protocolized analgesic approach to:
The investigators propose to randomize (1:1) 70 patients undergoing cardiac surgery to the perioperative EEG-guided MMGA bundle (described in full below) or standard-of-care management based primarily on the use of sevoflurane for unconsciousness and intermittent doses of fentanyl and hydromorphone for antinociception.
The team will test the intraoperative EEG-guided MMGA management strategy in combination with a postoperative protocolized analgesic approach to reduce the postoperative increase of surgical and delirium markers, reduce intraoperative abnormalities in brain health monitoring, ensure hemodynamic stability and decreased use of vasopressors in the operating rooms and reduce pain and opioid consumption postoperatively. The team will also investigate whether EEG-guided MMGA strategy reduces the incidence of perioperative neurocognitive dysfunction in cardiac surgical patients. This approach will further individualize care and minimize the use of intraoperative vasopressor-inotropic dose, dose of anesthetic medications, and postoperative opioids given to each patient potentially preventing hemodynamic complications and post-operative cognitive dysfunction after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal General Anesthesia (MMGA Bundle) - EEG Guided | Experimental |
Postop
|
|
| Standard of Care/Control | No Intervention | 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
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG Monitoring | Device | Perioperative monitoring, MMGA guided by EEG for intervention group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Plasma IL-6 Levels | 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. | Baseline, postoperative day 1, and postoperative day 2 |
| Increase in Plasma Neurofilament Light Levels | 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. | Baseline, postoperative day 1, and postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | 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. | From end of surgery to 48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Balachundhar Subramaniam, MD,MPH,FASA | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21190458 | Background | Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available. | |
| 29621031 | Background | Berger M, Terrando N, Smith SK, Browndyke JN, Newman MF, Mathew JP. Neurocognitive Function after Cardiac Surgery: From Phenotypes to Mechanisms. Anesthesiology. 2018 Oct;129(4):829-851. doi: 10.1097/ALN.0000000000002194. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multimodal General Anesthesia (MMGA Bundle) - EEG Guided |
Postop
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2023 |
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Group 1: Control - receives standard of care anesthesia and blinded EEG and Cerebral Oximetry(CO) monitoring Group 2: Intervention - receives MMGA bundle, guided by EEG monitoring, blinded CO will be passively collected
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| Ropivacaine | Drug | Intraoperative bilateral PIFB block with 20 mL of 0.2% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision (total of 40mL) PIFB on postoperative day 1 (provided they are extubated or getting ready to be extubated) to help with mobilization (for intervention group) |
|
| Ketamine | Drug | Intraoperative infusion |
|
| Remifentanil | Drug | Intraoperative infusion |
|
| Dexmedetomidine | Drug | Intraoperative infusion |
|
| Rocuronium | Drug | Intraoperative intermittent bolus |
|
| Propofol | Drug | Intraoperative infusion |
|
| Pain Scores | 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. | From end of surgery to 48 hours postoperatively |
| Burst Suppression | Duration of burst suppression was extracted and quantified from the intraoperative EEG record and compared between the MMGA and control groups. | intraoperative period, from anesthetic induction until the end of surgery |
| Postoperative Delirium | 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. | From postoperative day 1 until hospital discharge, an average of 4 days |
| Cognitive Function | 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. | Patients will be assessed for cognitive function at 1 month and 6 months following the date of surgery |
| Hemodynamic Stability - Total Vasopressor Dose | 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. | Intraoperative period, from induction of anesthesia until transfer from the operating room |
| 30252709 | Background | Brown EN, Pavone KJ, Naranjo M. Multimodal General Anesthesia: Theory and Practice. Anesth Analg. 2018 Nov;127(5):1246-1258. doi: 10.1213/ANE.0000000000003668. |
| 28564549 | Background | Volkow ND, Collins FS. The Role of Science in Addressing the Opioid Crisis. N Engl J Med. 2017 Jul 27;377(4):391-394. doi: 10.1056/NEJMsr1706626. Epub 2017 May 31. No abstract available. |
| 28431750 | Background | Mulier J. Opioid free general anesthesia: A paradigm shift? Rev Esp Anestesiol Reanim. 2017 Oct;64(8):427-430. doi: 10.1016/j.redar.2017.03.004. Epub 2017 Apr 18. No abstract available. English, Spanish. |
| 29912008 | Background | MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018 Sep;129(3):417-427. doi: 10.1097/ALN.0000000000002323. |
| 30721296 | Background | Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005. |
| 24812629 | Background | Nicolini F, Agostinelli A, Vezzani A, Manca T, Benassi F, Molardi A, Gherli T. The evolution of cardiovascular surgery in elderly patient: a review of current options and outcomes. Biomed Res Int. 2014;2014:736298. doi: 10.1155/2014/736298. Epub 2014 Apr 10. |
| 31439308 | Background | Mahanna-Gabrielli E, Schenning KJ, Eriksson LI, Browndyke JN, Wright CB, Culley DJ, Evered L, Scott DA, Wang NY, Brown CH 4th, Oh E, Purdon P, Inouye S, Berger M, Whittington RA, Price CC, Deiner S. State of the clinical science of perioperative brain health: report from the American Society of Anesthesiologists Brain Health Initiative Summit 2018. Br J Anaesth. 2019 Oct;123(4):464-478. doi: 10.1016/j.bja.2019.07.004. Epub 2019 Aug 19. |
| 31725024 | Background | Maheshwari K, Ahuja S, Khanna AK, Mao G, Perez-Protto S, Farag E, Turan A, Kurz A, Sessler DI. Association Between Perioperative Hypotension and Delirium in Postoperative Critically Ill Patients: A Retrospective Cohort Analysis. Anesth Analg. 2020 Mar;130(3):636-643. doi: 10.1213/ANE.0000000000004517. |
| 31279479 | Background | Ni K, Cooter M, Gupta DK, Thomas J, Hopkins TJ, Miller TE, James ML, Kertai MD, Berger M. Paradox of age: older patients receive higher age-adjusted minimum alveolar concentration fractions of volatile anaesthetics yet display higher bispectral index values. Br J Anaesth. 2019 Sep;123(3):288-297. doi: 10.1016/j.bja.2019.05.040. Epub 2019 Jul 3. |
| 30915984 | Background | Hesse S, Kreuzer M, Hight D, Gaskell A, Devari P, Singh D, Taylor NB, Whalin MK, Lee S, Sleigh JW, Garcia PS. Association of electroencephalogram trajectories during emergence from anaesthesia with delirium in the postanaesthesia care unit: an early sign of postoperative complications. Br J Anaesth. 2019 May;122(5):622-634. doi: 10.1016/j.bja.2018.09.016. Epub 2018 Oct 25. |
| 34722563 | Background | Shanker A, Abel JH, Narayanan S, Mathur P, Work E, Schamberg G, Sharkey A, Bose R, Rangasamy V, Senthilnathan V, Brown EN, Subramaniam B. Perioperative Multimodal General Anesthesia Focusing on Specific CNS Targets in Patients Undergoing Cardiac Surgeries: The Pathfinder Feasibility Trial. Front Med (Lausanne). 2021 Oct 14;8:719512. doi: 10.3389/fmed.2021.719512. eCollection 2021. |
| FG001 | 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
|
| Surgery |
|
| 1 month Follow-up |
|
| 6 month Follow-up |
|
| COMPLETED | For Primary Outcome |
|
| NOT COMPLETED |
|
|
One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group
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| ID | Title | Description |
|---|---|---|
| BG000 | Multimodal General Anesthesia (MMGA Bundle) - EEG Guided |
Postop
|
| BG001 | 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
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline measure values were compared between groups using the Wilcoxon rank-sum exact test, a nonparametric statistical test that assesses whether two independent samples come from the same distribution. This method does not assume normality and is appropriate for ordinal or continuous data that may not follow a normal distribution | One participant's baseline information is missing in the intervention group | Mean | Standard Deviation | years |
| |||||||||||||
| Sex: Female, Male | Baseline sex distribution was compared between groups using Fisher's exact test, a statistical method for assessing the association between categorical variables, especially appropriate for small sample sizes | One participant's baseline information is missing in the intervention group | Count of Participants | Participants |
| ||||||||||||||
| Race (NIH/OMB) | Baseline Race was compared between groups using Fisher's exact test, a statistical method for assessing the association between categorical variables, especially appropriate for small sample sizes | One participant's baseline information is missing in the intervention group | Count of Participants | Participants |
| ||||||||||||||
| Ethnicity (NIH/OMB) | Baseline Ethnicity was compared between groups using Fisher's exact test, a statistical method for assessing the association between categorical variables, especially appropriate for small sample sizes | One participant's baseline information is missing in the intervention group, and one participant's ethnicity data is missing in the control group | Count of Participants | Participants |
| ||||||||||||||
| Baseline plasma IL-6 and NFL Levels | Plasma interleukin-6 (IL-6) and Neurofilament Light (NFL) levels will be measured at baseline | 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. | Mean | Standard Deviation | pg/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Increase in Plasma IL-6 Levels | 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. | 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. | Posted | Mean | Standard Deviation | pg/mL | Baseline, postoperative day 1, and postoperative day 2 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Increase in Plasma Neurofilament Light Levels | 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. | 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. | Posted | Mean | Standard Deviation | pg/mL | Baseline, postoperative day 1, and postoperative day 2 |
| ||||||||||||||||||||||||||||||
| Secondary | Opioid Consumption | 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. | 2 subjects in intervention group and 1 subject in control group withdrew from study after the consent before the start of study procedure | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | From end of surgery to 48 hours postoperatively |
| ||||||||||||||||||||||||||||||
| Secondary | Pain Scores | 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. | Posted | Mean | Standard Deviation | Scores on a scale | From end of surgery to 48 hours postoperatively |
| |||||||||||||||||||||||||||||||
| Secondary | Burst Suppression | Duration of burst suppression was extracted and quantified from the intraoperative EEG record and compared between the MMGA and control groups. | 5 subjects from the intervention group and 4 subjects in control group are removed from analysis due to artifacts in EEG data | Posted | Mean | Standard Deviation | minutes | intraoperative period, from anesthetic induction until the end of surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Postoperative Delirium | 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. | Posted | Number | Participants with delirium | From postoperative day 1 until hospital discharge, an average of 4 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Cognitive Function | 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. | Lost to follow-up | Posted | Mean | Standard Deviation | scores on a scale | Patients will be assessed for cognitive function at 1 month and 6 months following the date of surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Hemodynamic Stability - Total Vasopressor Dose | 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. | 3 subjects change of consent status before surgery | Posted | Mean | Standard Deviation | norepinephrine equivalents (mcg/kg/min) | Intraoperative period, from induction of anesthesia until transfer from the operating room |
|
From the day of surgery until postoperative day 4
Adverse events were defined and collected per institutional CCI policy, which may differ slightly from ClinicalTrials.gov definitions. Events were recorded daily during hospitalization for up to four postoperative days, regardless of relatedness, and included both serious and non-serious events. Structured assessments captured clinical events such as arrhythmias, hypotension, infection, hematoma, and local anesthetic systemic toxicity. Analyses included all participants who received the assigned
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multimodal General Anesthesia (MMGA Bundle) - EEG Guided |
Postop
| 0 | 33 | 0 | 33 | 0 | 33 |
| EG001 | 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
| 0 | 34 | 0 | 34 | 0 | 34 |
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This single-center trial enrolled a small sample and was not powered for clinical outcomes such as delirium. Some biomarker and EEG data were missing or artifact-limited, and anesthesia depth may have differed between groups. These factors may limit generalizability and interpretation of results.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Balachundhar Subramaniam | Beth Israel Deaconess Medical Center | 617-278-8000 | bsubrama@bidmc.harvard.edu |
| Oct 27, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D010146 | Pain |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D007649 | Ketamine |
| D000077208 | Remifentanil |
| D020927 | Dexmedetomidine |
| D000077123 | Rocuronium |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
|
|
|
|
| NFL Baseline |
|
|
| Il-6 - POD1 |
|
|
| IL-6 - POD2 |
|
|
| OG001 | 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
|
|
|
| OG001 |
| 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
|
|
|
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
|
|
|
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
Standard pain management protocol
Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
Propofol infusion may be added/used for sedation based on the treating physician's discretion
Lidocaine patches
Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion
|
|
|
|
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
|
|
|
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
|
|
|