Effects of Anesthetic Technique on NK Cells

NCT02669186 | Unknown DMC

• 1 other identifier: Pro00039201-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anesthesia; Cancer

Keywords

analgesia; cancer; natural killer cell; opioid

Outcome Measures

Primary Outcomes (1)

• Natural Killer Cell Cytotoxicty

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

  One Year

Study Arms (2)

'Bupivacaine + Fentanyl' (Opioid Group)

EXPERIMENTAL

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

Bupivacaine (Local Anesthetic Group)

ACTIVE COMPARATOR

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

Interventions

Bupivacaine + Fentanyl DRUG

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.

Also known as: Sublimaze

'Bupivacaine + Fentanyl' (Opioid Group)

Bupivacaine DRUG

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

Bupivacaine (Local Anesthetic Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old of either gender
• Diagnosis of abdominal tumor scheduled for exploratory laparotomy with study surgeon
• Must be able to have an epidural

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• 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.

  PMID: 25009196 BACKGROUND

• 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.

  PMID: 8623949 BACKGROUND

• 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.

  PMID: 23659826 BACKGROUND

MeSH Terms

Conditions

Pain; Neoplasms; Agnosia

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Roya Yumul, MD, PhD

  Program Director, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Anesthesiology

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: February 1, 2016
• Study Start: July 10, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

US (1)