The PATHFINDER Study: A Feasibility Trial (PATHFINDER)
2021년 1월 27일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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
연구 유형
중재적
등록 (실제)
22
단계
- 초기 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
60년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
Postoperative
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수술 중 주입
수술 중 주입
수술 중 주입
수술 중 간헐적 볼루스
수술 중 주입
Intraoperative bilateral PIFB block with 20 mL of 0.25% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision
Intraoperative inhaled as needed
Post-operative infusion
Post-operative infusion
Perioperative monitoring
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다른: 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.
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Perioperative monitoring
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of Delirium
기간: Participants will be followed for the duration of the hospital stay, an average of 5 days
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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.
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Participants will be followed for the duration of the hospital stay, an average of 5 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to extubation
기간: Time of ICU admission until time of extubation in ICU, an average of 6 hours
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Time to extubation will be noted from ICU data
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Time of ICU admission until time of extubation in ICU, an average of 6 hours
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Montreal Cognitive Assessment (MoCA)
기간: On the day of discharge, an average of 6 days
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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.
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On the day of discharge, an average of 6 days
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Pain scores
기간: At 4-8 hourly intervals every day until discharge, an average of 6 days
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Patient reported pain scores on a scale from 0-10 (0 no pain,10 extreme pain), until discharge for the index admission.
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At 4-8 hourly intervals every day until discharge, an average of 6 days
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Total opioid and supplemental analgesic consumption
기간: 48 hours, post-operative
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The total opioid dosage and supplemental analgesic dosage received in the first 48 hours postoperatively will be abstracted from the medical record.
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48 hours, post-operative
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ICU
기간: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
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Total duration of stay in ICU for the index admission
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Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
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ICU/hospital length of stay
기간: Time of stay in the hospital until discharge to floor or rehab, an average of 5 days
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Their stay in the hospital for the index admission
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Time of stay in the hospital until discharge to floor or rehab, an average of 5 days
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In-hospital complications
기간: 7 days post-op on an average
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stroke, myocardial infarction (MI), acute kidney injury, pneumonia, reintubation, congestive heart failure, sepsis, reopening of sternum and all-cause mortality
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7 days post-op on an average
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Follow up incidence of delirium
기간: Patients will be assessed for delirium at 1 month and 6 months following the date of surgery
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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.
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Patients will be assessed for delirium at 1 month and 6 months following the date of surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
- Pesonen A, Suojaranta-Ylinen R, Hammaren E, Kontinen VK, Raivio P, Tarkkila P, Rosenberg PH. Pregabalin has an opioid-sparing effect in elderly patients after cardiac surgery: a randomized placebo-controlled trial. Br J Anaesth. 2011 Jun;106(6):873-81. doi: 10.1093/bja/aer083. Epub 2011 Apr 6.
- 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.
- Papaioannou A, Fraidakis O, Michaloudis D, Balalis C, Askitopoulou H. The impact of the type of anaesthesia on cognitive status and delirium during the first postoperative days in elderly patients. Eur J Anaesthesiol. 2005 Jul;22(7):492-9. doi: 10.1017/s0265021505000840.
- Rudolph JL, Jones RN, Levkoff SE, Rockett C, Inouye SK, Sellke FW, Khuri SF, Lipsitz LA, Ramlawi B, Levitsky S, Marcantonio ER. Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Circulation. 2009 Jan 20;119(2):229-36. doi: 10.1161/CIRCULATIONAHA.108.795260. Epub 2008 Dec 31.
- 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.
- 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.
- Ballard C, Jones E, Gauge N, Aarsland D, Nilsen OB, Saxby BK, Lowery D, Corbett A, Wesnes K, Katsaiti E, Arden J, Amoako D, Prophet N, Purushothaman B, Green D. Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial. PLoS One. 2012;7(6):e37410. doi: 10.1371/journal.pone.0037410. Epub 2012 Jun 15. Erratum In: PLoS One. 2012;7(9). doi:10.1371/annotation/1cc38e55-23e8-44a5-ac2b-43c7b2a880f9. Amaoko, Derek [corrected to Amoako, Derek]. PLoS One. 2013;8(9). doi:10.1371/annotation/c0569644-bea1-4c38-af9a-75d1168e3142.
- 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.
- Volkow ND, Collins FS. The Role of Science in the Opioid Crisis. N Engl J Med. 2017 Nov 2;377(18):1798. doi: 10.1056/NEJMc1711494. No abstract available.
- Burkhart CS, Dell-Kuster S, Gamberini M, Moeckli A, Grapow M, Filipovic M, Seeberger MD, Monsch AU, Strebel SP, Steiner LA. Modifiable and nonmodifiable risk factors for postoperative delirium after cardiac surgery with cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2010 Aug;24(4):555-9. doi: 10.1053/j.jvca.2010.01.003. Epub 2010 Mar 15.
- Urban MK, Ya Deau JT, Wukovits B, Lipnitsky JY. Ketamine as an adjunct to postoperative pain management in opioid tolerant patients after spinal fusions: a prospective randomized trial. HSS J. 2008 Feb;4(1):62-5. doi: 10.1007/s11420-007-9069-9. Epub 2007 Dec 19.
- McNicol E, Horowicz-Mehler N, Fisk RA, Bennett K, Gialeli-Goudas M, Chew PW, Lau J, Carr D; Americal Pain Society. Management of opioid side effects in cancer-related and chronic noncancer pain: a systematic review. J Pain. 2003 Jun;4(5):231-56. doi: 10.1016/s1526-5900(03)00556-x.
- Depth of anaesthesia monitors - Bispectral Index (BIS), E-Entropy and Narcotrend-Compact M | Guidance and guidelines | NICE [Internet]. [cited 2018 Dec 24];Available from: https://www.nice.org.uk/guidance/dg6
- Wilson PT, Spitzer RL. Major changes in psychiatric nomenclature. Reconciling existing psychiatric medical records with the new American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders. Hosp Community Psychiatry. 1968 Jun;19(6):169-74. No abstract available.
- Sauer AM, Slooter AJ, Veldhuijzen DS, van Eijk MM, Devlin JW, van Dijk D. Intraoperative dexamethasone and delirium after cardiac surgery: a randomized clinical trial. Anesth Analg. 2014 Nov;119(5):1046-52. doi: 10.1213/ANE.0000000000000248.
- Arora RC, Djaiani G, Rudolph JL. Detection, Prevention, and Management of Delirium in the Critically Ill Cardiac Patient and Patients Who Undergo Cardiac Procedures. Can J Cardiol. 2017 Jan;33(1):80-87. doi: 10.1016/j.cjca.2016.08.020. Epub 2016 Oct 5.
- Delirium: prevention, diagnosis and management | Guidance and guidelines | NICE [Internet]. [cited 2018 Dec 20];Available from: https://www.nice.org.uk/guidance/cg103
- Stoppe C, Fahlenkamp AV, Rex S, Veeck NC, Gozdowsky SC, Schalte G, Autschbach R, Rossaint R, Coburn M. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study. Br J Anaesth. 2013 Sep;111(3):406-16. doi: 10.1093/bja/aet072. Epub 2013 Apr 11.
- Lurati Buse GA, Schumacher P, Seeberger E, Studer W, Schuman RM, Fassl J, Kasper J, Filipovic M, Bolliger D, Seeberger MD. Randomized comparison of sevoflurane versus propofol to reduce perioperative myocardial ischemia in patients undergoing noncardiac surgery. Circulation. 2012 Dec 4;126(23):2696-704. doi: 10.1161/CIRCULATIONAHA.112.126144. Epub 2012 Nov 7.
- Jia Y, Jin G, Guo S, Gu B, Jin Z, Gao X, Li Z. Fast-track surgery decreases the incidence of postoperative delirium and other complications in elderly patients with colorectal carcinoma. Langenbecks Arch Surg. 2014 Jan;399(1):77-84. doi: 10.1007/s00423-013-1151-9. Epub 2013 Dec 13.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 8월 20일
기본 완료 (실제)
2020년 2월 19일
연구 완료 (실제)
2020년 7월 7일
연구 등록 날짜
최초 제출
2019년 7월 9일
QC 기준을 충족하는 최초 제출
2019년 7월 10일
처음 게시됨 (실제)
2019년 7월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 27일
마지막으로 확인됨
2021년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 심근 허혈
- 심장 질환
- 심혈관 질환
- 혈관 질환
- 동맥 경화증
- 동맥 폐색 질환
- 관상 동맥 질환
- 관상동맥 질환
- 약물의 생리적 효과
- 아드레날린 작용제
- 신경 전달 물질
- 약리작용의 분자기전
- 중추신경계 억제제
- 말초 신경계 작용제
- 진통제
- 감각 시스템 에이전트
- 마취제, 해리제
- 마취제, 정맥주사
- 마취제, 일반
- 마취제
- 흥분성 아미노산 길항제
- 흥분성 아미노산 제제
- 진통제, 비마약성
- 혈소판 응집 억제제
- 아드레날린성 알파-2 수용체 작용제
- 아드레날린성 알파 작용제
- 아드레날린 작용제
- 진통제, 오피오이드
- 마약류
- 수면제 및 진정제
- 마취제, 국소
- 마취제, 흡입
- 신경근 치료제
- 신경근 비탈분극제
- 신경근 차단제
- 케타민
- 레미펜타닐
- 프로포폴
- 덱스메데토미딘
- 세보플루란
- 로피바카인
- 로쿠로늄
기타 연구 ID 번호
- 2019P000407
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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