Perioperative Multimodal General Anesthesia Focusing on Specific CNS Targets in Patients Undergoing Cardiac Surgeries
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Incidence of Delirium
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
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
Intraoperative
The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.
- Routine anesthetic induction
- Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
- Ketamine (0.06 to 0.12 mg.kg/hr)
- Remifentanil (0.05-0.2 mcg/kg/min)
- Dexmedetomidine (0.2-1.0 mcg/kg/hr)
- Rocuronium intermittent bolus (TOF)
- Propofol infusion ± Sevoflurane titrated based on EEG monitoring
Postoperative
- Standard pain management protocol
- Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
- Infusion continued till extubation
- Propofol infusion may be added/used for sedation based on the treating physician's discretion
干预措施: Ropivacaine (Drug)
Multimodal General Anesthesia
Intraoperative
The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.
- Routine anesthetic induction
- Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
- Ketamine (0.06 to 0.12 mg.kg/hr)
- Remifentanil (0.05-0.2 mcg/kg/min)
- Dexmedetomidine (0.2-1.0 mcg/kg/hr)
- Rocuronium intermittent bolus (TOF)
- Propofol infusion ± Sevoflurane titrated based on EEG monitoring
Postoperative
- Standard pain management protocol
- Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
- Infusion continued till extubation
- Propofol infusion may be added/used for sedation based on the treating physician's discretion
干预措施: Ketamine (Drug)
Multimodal General Anesthesia
Intraoperative
The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.
- Routine anesthetic induction
- Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
- Ketamine (0.06 to 0.12 mg.kg/hr)
- Remifentanil (0.05-0.2 mcg/kg/min)
- Dexmedetomidine (0.2-1.0 mcg/kg/hr)
- Rocuronium intermittent bolus (TOF)
- Propofol infusion ± Sevoflurane titrated based on EEG monitoring
Postoperative
- Standard pain management protocol
- Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
- Infusion continued till extubation
- Propofol infusion may be added/used for sedation based on the treating physician's discretion
干预措施: Remifentanil (Drug)
Multimodal General Anesthesia
Intraoperative
The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.
- Routine anesthetic induction
- Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
- Ketamine (0.06 to 0.12 mg.kg/hr)
- Remifentanil (0.05-0.2 mcg/kg/min)
- Dexmedetomidine (0.2-1.0 mcg/kg/hr)
- Rocuronium intermittent bolus (TOF)
- Propofol infusion ± Sevoflurane titrated based on EEG monitoring
Postoperative
- Standard pain management protocol
- Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
- Infusion continued till extubation
- Propofol infusion may be added/used for sedation based on the treating physician's discretion
干预措施: Dexmedetomidine (Drug)
Multimodal General Anesthesia
Intraoperative
The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.
- Routine anesthetic induction
- Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
- Ketamine (0.06 to 0.12 mg.kg/hr)
- Remifentanil (0.05-0.2 mcg/kg/min)
- Dexmedetomidine (0.2-1.0 mcg/kg/hr)
- Rocuronium intermittent bolus (TOF)
- Propofol infusion ± Sevoflurane titrated based on EEG monitoring
Postoperative
- Standard pain management protocol
- Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
- Infusion continued till extubation
- Propofol infusion may be added/used for sedation based on the treating physician's discretion
干预措施: Rocuronium (Drug)
Multimodal General Anesthesia
Intraoperative
The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.
- Routine anesthetic induction
- Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
- Ketamine (0.06 to 0.12 mg.kg/hr)
- Remifentanil (0.05-0.2 mcg/kg/min)
- Dexmedetomidine (0.2-1.0 mcg/kg/hr)
- Rocuronium intermittent bolus (TOF)
- Propofol infusion ± Sevoflurane titrated based on EEG monitoring
Postoperative
- Standard pain management protocol
- Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
- Infusion continued till extubation
- Propofol infusion may be added/used for sedation based on the treating physician's discretion
干预措施: Propofol (Drug)
Multimodal General Anesthesia
Intraoperative
The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.
- Routine anesthetic induction
- Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
- Ketamine (0.06 to 0.12 mg.kg/hr)
- Remifentanil (0.05-0.2 mcg/kg/min)
- Dexmedetomidine (0.2-1.0 mcg/kg/hr)
- Rocuronium intermittent bolus (TOF)
- Propofol infusion ± Sevoflurane titrated based on EEG monitoring
Postoperative
- Standard pain management protocol
- Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
- Infusion continued till extubation
- Propofol infusion may be added/used for sedation based on the treating physician's discretion
干预措施: Sevoflurane (Drug)
Multimodal General Anesthesia
Intraoperative
The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.
- Routine anesthetic induction
- Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
- Ketamine (0.06 to 0.12 mg.kg/hr)
- Remifentanil (0.05-0.2 mcg/kg/min)
- Dexmedetomidine (0.2-1.0 mcg/kg/hr)
- Rocuronium intermittent bolus (TOF)
- Propofol infusion ± Sevoflurane titrated based on EEG monitoring
Postoperative
- Standard pain management protocol
- Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
- Infusion continued till extubation
- Propofol infusion may be added/used for sedation based on the treating physician's discretion
干预措施: EEG monitoring (Device)
Standard Practice with EEG monitoring
The initial 2 patients will receive standard anesthesia practice and perioperative EEG monitoring will be recorded to learn the patterns associated with our standard practice.
干预措施: EEG monitoring (Device)
结局指标
主要结局
Incidence of Delirium
时间窗: 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.
次要结局
- Time to extubation(Time of ICU admission until time of extubation in ICU, an average of 6 hours)
- ICU/hospital length of stay(Time of stay in the hospital until discharge to floor or rehab, an average of 5 days)
- In-hospital complications(7 days post-op on an average)
- Montreal Cognitive Assessment (MoCA)(On the day of discharge, an average of 6 days)
- ICU(Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days)
- Follow up incidence of delirium(Patients will be assessed for delirium at 1 month and 6 months following the date of surgery)
- Pain scores(At 4-8 hourly intervals every day until discharge, an average of 6 days)
- Total opioid and supplemental analgesic consumption(48 hours, post-operative)
研究者
Balachundhar Subramaniam
Associate Professor of Anesthesia
Beth Israel Deaconess Medical Center