Effects of Anesthetic Technique on NK Cells

Pain Clinical Trial

Official title:

Effects of Anesthetic Technique on Natural Killer Cell Population and Cytotoxicity

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02669186
• Other study ID #: Pro00039201-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 10, 2019
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Cancer
• Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural Killer Cell Cytotoxicty	Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression.	One Year