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The PATHFINDER Study: A Feasibility Trial (PATHFINDER)

27. januar 2021 opdateret af: Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 60 years
  2. 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:

  1. Preoperative left ventricular ejection fraction (LVEF) <30%
  2. Emergent surgery
  3. Non-English speaking
  4. Cognitive impairment as defined by total MoCA score < 10
  5. Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
  6. Significant visual impairment
  7. 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)
  8. Hypersensitivity to any of the study medications
  9. 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
  10. Liver dysfunction (liver enzymes > 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

  1. Routine anesthetic induction
  2. 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
  3. Ketamine (0.06 to 0.12 mg.kg/hr)
  4. Remifentanil (0.05-0.2 mcg/kg/min)
  5. Dexmedetomidine (0.2-1.0 mcg/kg/hr)
  6. Rocuronium intermittent bolus (TOF)
  7. Propofol infusion ± Sevoflurane titrated based on EEG monitoring

Postoperative

  1. Standard pain management protocol
  2. Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
  3. Infusion continued till extubation
  4. Propofol infusion may be added/used for sedation based on the treating physician's discretion
Medicin: Ketamin
Intraoperativ infusion
Medicin: Remifentanil
Intraoperativ infusion
Medicin: Dexmedetomidin
Intraoperativ infusion
Medicin: Rocuronium
Intraoperativ intermitterende bolus
Medicin: Propofol
Intraoperativ infusion
Medicin: Ropivacaine
Intraoperative bilateral PIFB block with 20 mL of 0.25% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision
Medicin: Sevoflurane
Intraoperative inhaled as needed
Medicin: Dexmedetomidine
Post-operative infusion
Medicin: Propofol
Post-operative infusion
Enhed: EEG monitoring
Perioperative monitoring
Andet: 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.
Enhed: EEG monitoring
Perioperative monitoring

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Delirium
Tidsramme: 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.
Participants will be followed for the duration of the hospital stay, an average of 5 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to extubation
Tidsramme: Time of ICU admission until time of extubation in ICU, an average of 6 hours
Time to extubation will be noted from ICU data
Time of ICU admission until time of extubation in ICU, an average of 6 hours
Montreal Cognitive Assessment (MoCA)
Tidsramme: 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.
On the day of discharge, an average of 6 days
Pain scores
Tidsramme: 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.
At 4-8 hourly intervals every day until discharge, an average of 6 days
Total opioid and supplemental analgesic consumption
Tidsramme: 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.
48 hours, post-operative
ICU
Tidsramme: 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
Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
ICU/hospital length of stay
Tidsramme: 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
Time of stay in the hospital until discharge to floor or rehab, an average of 5 days
In-hospital complications
Tidsramme: 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
7 days post-op on an average
Follow up incidence of delirium
Tidsramme: 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.
Patients will be assessed for delirium at 1 month and 6 months following the date of surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beth Israel Deaconess Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. august 2019

Primær færdiggørelse (Faktiske)

19. februar 2020

Studieafslutning (Faktiske)

7. juli 2020

Datoer for studieregistrering

Først indsendt

9. juli 2019

Først indsendt, der opfyldte QC-kriterier

10. juli 2019

Først opslået (Faktiske)

11. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2019P000407

Plan for individuelle deltagerdata (IPD)

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INGEN

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produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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