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Effects of Anesthetic Technique on NK Cells

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02669186
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
52.7
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed study is a pilot prospective, single-blinded, randomized controlled trial evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural killer cell population size and cytotoxicity in patients undergoing exploratory abdominal laparotomies.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Anesthetic Technique on Natural Killer Cell Population and Cytotoxicity
Actual Study Start Date :
Jul 10, 2019
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 'Bupivacaine + Fentanyl' (Opioid Group)

Group 1 (opioid group) will receive general endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control.

Drug: Bupivacaine + Fentanyl
General endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control.
Other Names:
  • Sublimaze

    		•
    Active Comparator: Bupivacaine (Local Anesthetic Group)

    Group 2 (local anesthetic group) will receive general endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control.

    Drug: Bupivacaine
    General endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control

    Outcome Measures

    Primary Outcome Measures

    1. Natural Killer Cell Cytotoxicty [One Year]

      Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18 - 80 years old of either gender

    • Diagnosis of abdominal tumor scheduled for exploratory laparotomy with study surgeon

    • Must be able to have an epidural

    Exclusion Criteria:

    • ASA IV and above

    • Intolerance, allergy, or contraindication to use of either fentanyl or bupivacaine.

    • Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)

    • Uncontrolled hypertension (BP > 140/90)

    • Cardiac arrhythmias particularly prolonged QT syndrome

    • Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants

    • Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis

    • Pregnant or lactating women

    • Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg

    • Chronic renal failure ( creatinine > 2.0 mg/dL)

    • Liver failure e.g., active cirrhosis

    • Alcohol or substance abuse within in the past 3 months

    • Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)

    • Neuropathic pain

    • Chronic opioid consumption (>30mg oxycodone or greater per day)

    • Cachexia from any cause

    • Systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery

    • HIV or other immunosuppressive condition

    • Preoperative INR > 1.4 or platelet count < 100

    • Sepsis or overlying skin cellulitis at epidural catheter insertion site

    • Inability to tolerate/unwillingness to have an epidural catheter for intraoperative/postoperative pain control for any reason, including prior back surgery resulting in distorted anatomy that precludes neuraxial anesthesia.

    • Inability to tolerate an epidural solution of either fentanyl or bupivacaine or needs another form of specialized pain control.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars Sinai Medical Center Los Angeles California United States 90048

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center

    Investigators

    • Principal Investigator: Roya Yumul, MD, PhD, Program Director, Department of Anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Roya Yumul, M.D.,PhD., Program Director, Anesthesiology, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT02669186
    Other Study ID Numbers:
    • Pro00039201-1
    First Posted:
    Feb 1, 2016
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Roya Yumul, M.D.,PhD., Program Director, Anesthesiology, Cedars-Sinai Medical Center
    analgesia
    cancer
    natural killer cell
    opioid
    Additional relevant MeSH terms:
    Fentanyl
    Bupivacaine

    Study Results

    No Results Posted as of Feb 11, 2022