CompletedEarly Phase 1ketamine

The PATHFINDER Study: A Feasibility Trial

Sponsored by Beth Israel Deaconess Medical Center

NCT ID
NCT04016740
Target Enrollment
22 participants
Start Date
2019-08-20
Est. Completion
2020-07-07

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.

Conditions Studied

Coronary Artery DiseaseDelirium

Interventions

  • Ropivacaine
  • Ketamine
  • Remifentanil
  • Dexmedetomidine
  • Rocuronium
  • Propofol
  • Sevoflurane
  • Dexmedetomidine
  • Propofol
  • EEG monitoring

Eligibility

Age:60 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
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.

Study Locations (1)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

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