Effects of Anesthetic Technique on NK Cells

• Status: Enrolling by invitation
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Anesthetics; Bupivacaine; Fentanyl; Pharmaceutical Solutions

Criteria

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.