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临床试验/NCT05279898
NCT05279898已完成不适用

Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing carDiac surgERies - the PATHFINDER II Study

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年2月28日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Increase in Plasma IL-6 Levels
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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:

  1. reduce the incidence of perioperative neurocognitive dysfunction in cardiac surgical patients
  2. ensure hemodynamic stability and decrease use of vasopressors in the operating rooms
  3. reduce pain and opioid consumption postoperatively

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 60 years
  • •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.

排除标准

  • •Preoperative left ventricular ejection fraction (LVEF) <30%
  • •Emergent surgery
  • •Non-English speaking
  • •Cognitive impairment as defined by total MoCA score < 10
  • •Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
  • •Significant visual impairment
  • •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)
  • •Hypersensitivity to any of the study medications
  • •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
  • •Liver dysfunction (liver enzymes > 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.

研究组 & 干预措施

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Experimental
  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)
  1. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
  2. Propofol infusion may be added/used for sedation based on the treating physician's discretion
  3. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group)
  4. Lidocaine patches

干预措施: EEG Monitoring (Device)

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Experimental
  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)
  1. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
  2. Propofol infusion may be added/used for sedation based on the treating physician's discretion
  3. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group)
  4. Lidocaine patches

干预措施: Ropivacaine (Drug)

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Experimental
  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)
  1. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
  2. Propofol infusion may be added/used for sedation based on the treating physician's discretion
  3. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group)
  4. Lidocaine patches

干预措施: Ketamine (Drug)

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Experimental
  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)
  1. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
  2. Propofol infusion may be added/used for sedation based on the treating physician's discretion
  3. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group)
  4. Lidocaine patches

干预措施: Remifentanil (Drug)

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Experimental
  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)
  1. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
  2. Propofol infusion may be added/used for sedation based on the treating physician's discretion
  3. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group)
  4. Lidocaine patches

干预措施: Dexmedetomidine (Drug)

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Experimental
  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)
  1. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
  2. Propofol infusion may be added/used for sedation based on the treating physician's discretion
  3. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group)
  4. Lidocaine patches

干预措施: Rocuronium (Drug)

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Experimental
  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)
  1. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
  2. Propofol infusion may be added/used for sedation based on the treating physician's discretion
  3. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group)
  4. Lidocaine patches

干预措施: Propofol (Drug)

结局指标

主要结局

Increase in Plasma IL-6 Levels

时间窗: Baseline, postoperative day 1, and postoperative day 2

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.

Increase in Plasma Neurofilament Light Levels

时间窗: 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.

次要结局

  • Opioid Consumption(From end of surgery to 48 hours postoperatively)
  • Pain Scores(From end of surgery to 48 hours postoperatively)
  • Burst Suppression(intraoperative period, from anesthetic induction until the end of surgery)
  • Postoperative Delirium(From postoperative day 1 until hospital discharge, an average of 4 days)
  • 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(Intraoperative period, from induction of anesthesia until transfer from the operating room)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Balachundhar Subramaniam

Balachundhar Subramaniam MD MPH FASA, Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (1)

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