Clinical trial NCT02669186: Effects of Anesthetic Technique on NK Cells
Official title: Effects of Anesthetic Technique on Natural Killer Cell Population and Cytotoxicity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain
Anesthesia
Cancer
Keywords: analgesia
cancer
natural killer cell
opioid
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Natural Killer Cell Cytotoxicty
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Program Director, Department of Anesthesiology
name: Roya Yumul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.
citation: Beilin B, Shavit Y, Hart J, Mordashov B, Cohn S, Notti I, Bessler H. Effects of anesthesia based on large versus small doses of fentanyl on natural killer cell cytotoxicity in the perioperative period. Anesth Analg. 1996 Mar;82(3):492-7. doi: 10.1097/00000539-199603000-00011.
citation: Cata JP, Bauer M, Sokari T, Ramirez MF, Mason D, Plautz G, Kurz A. Effects of surgery, general anesthesia, and perioperative epidural analgesia on the immune function of patients with non-small cell lung cancer. J Clin Anesth. 2013 Jun;25(4):255-62. doi: 10.1016/j.jclinane.2012.12.007. Epub 2013 May 7.