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Completed

NCT Number: NCT04016740

The PATHFINDER Study: A Feasibility Trial

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Confusion Coronary Disease Delirium Heart Diseases Mental Disorders Myocardial Ischemia Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ropivacaine

Drug

Intraoperative bilateral PIFB block with 20 mL of 0.25% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision

ketamine

Drug

Intraoperative infusion

Remifentanil

Drug

Intraoperative infusion

Dexmedetomidine

Drug

Intraoperative infusion

Rocuronium

Drug

Intraoperative intermittent bolus

Propofol

Drug

Intraoperative infusion

Sevoflurane

Drug

Intraoperative inhaled as needed

EEG monitoring

Device

Perioperative monitoring

Primary outcomes

  1. Incidence of Delirium

    Time frame: 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 outcomes

  1. Time to extubation

    Time frame: Time of ICU admission until time of extubation in ICU, an average of 6 hours

    Time to extubation will be noted from ICU data

  2. Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  3. Pain scores

    Time frame: 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.

  4. Total opioid and supplemental analgesic consumption

    Time frame: 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.

  5. ICU

    Time frame: 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

  6. ICU/hospital length of stay

    Time frame: 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

  7. In-hospital complications

    Time frame: 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

  8. Follow up incidence of delirium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Perioperative Multimodal General Anesthesia Focusing on Specific CNS Targets in Patients Undergoing Cardiac Surgeries

Acronym: PATHFINDER

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2019
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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