Effects of Anesthetic Technique on NK Cells

August 28, 2023 updated by: Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Effects of Anesthetic Technique on Natural Killer Cell Population and Cytotoxicity

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natural Killer Cell Cytotoxicty
Time Frame: One Year
Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression.
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimated)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00039201-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Bupivacaine + Fentanyl

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe