Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04079673
Collaborator
(none)
60
1
2
33.4
1.8

Study Details

Study Description

Brief Summary

As the only curative treatment for end-stage liver diseases, liver transplantation has been widely carried out around the world. The shortage of organs from deceased donors facilitate the adoption of living donor liver transplantation. Living donor hepatectomy is the most massive operation a healthy person could undergo, so donor safety is of utmost importance. However, previous studies focused on the outcomes of liver transplant recipients. There are still many uncertainties about the recovery in living liver donors.

The body microorganisms that reside in the human intestinal tract, referred to as the gut microbiota, are essential to human metabolism and immunity. The physiological functions of microbiota include defense against pathogens, providing nutrients such as vitamin B12 folate and vitamin K, and modulating gut integrity and permeability. Despite relatively stable microbiota during life, different illnesses, surgeries, medications dietary factors, and lifestyle changes could contribute to the imbalance of ecosystems resulting many gastrointestinal and extra-gastrointestinal disorders. Many researches have established a relationship between the gut microbiome and patients with liver disease such as liver cirrhosis, alcoholic liver disease and obesity related liver diseases etc. These liver disorders are associated with bacterial overgrowth, dysbiosis, and increased intestinal permeability. However, the relationship between hepatectomy and microbiota has not been fully investigated, especially in healthy liver donors.

Many routine perioperative management can impact the state of the microbiome and therefore can impact clinical outcomes, like bowel preparation and antibiotics. Potential factors affecting the gut microbiota also include perioperative manipulation, stress released hormones, and opioids. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including volatile anesthetics and opioids, is associated with altered gut microbiota. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages. Epidural analgesia has been proved to improve gastrointestinal function in major abdominal and thoracic surgery. However, the effect of perioperative epidural anesthesia and analgesia on microbiota is not clear.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Patient controlled epidural analgesia
  • Drug: Intravenous patient controlled analgesia
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Effect of Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota and Gastrointestinal Function Recovery in Living Donor Hepatectomy
Actual Study Start Date :
Oct 19, 2019
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patient controlled epidural analgesia

Use of patient controlled epidural analgesia (PCEA) for postoperative pain control

Procedure: Patient controlled epidural analgesia
Patient controlled epidural analgesia with marcaine 0.66mg/ml +fentanyl 1.75mcg/ml for postoperative pain control
Other Names:
  • PCEA
  • Sham Comparator: Intravenous patient controlled analgesia

    Use of intravenous patient controlled analgesia(IVPCA) for postoperative pain control

    Drug: Intravenous patient controlled analgesia
    Intravenous patient controlled analgesia with morphine 1mg/ml for postoperative pain control
    Other Names:
  • IVPCA
  • Outcome Measures

    Primary Outcome Measures

    1. Microbiota analysis [one month]

      16S metagenomic sequence processing

    Secondary Outcome Measures

    1. LPS-binding protein [one month]

      LPS-binding protein(mcg/mL)

    2. Intestinal fatty acid binding protein [one month]

      Intestinal fatty acid binding protein(ng/mL)

    3. IgA [one month]

      IgA(mcg/mL)

    4. IL-6 [one month]

      IL-6(ng/mL)

    5. I-FEED scoring [one week]

      I-FEED scoring system for postoperative gastrointestinal function: Intake(score): tolerating oral diet(0), limited tolerance(1), complete Intolerance(3) Feeling nauseated(score): none(0), responsive to treatment(1), resistant to treatment(3) Emesis(score): none(0), ≧1 episode of low volume(<100mL) and none bilious(1), ≧1 episode of high volume(>100mL) or bilious(3) Exam(score): no distension(0), distension without tympany(1), significant distension with tympany(3) Duration of symptoms(score):0-24hours(0),24-72hours(1),>72hours(2) Total score: 0-2 normal, 3-5 postoperative GI intolerance, >6 postoperative GI dysfunction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Expected to receive living liver hepatectomy in National Taiwan University Hospital, age between 20 and 55 years old.
    Exclusion Criteria:
    1. Previous use of antibiotics within four weeks.

    2. Previous gastrointestinal surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, National Taiwan University Hospital Taipei City Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Kuang-Cheng Chan, M.D.,PhD, Department of Anesthesiology, Natioanal Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04079673
    Other Study ID Numbers:
    • 201812090RINC
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Oct 21, 2021
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital

    Study Results

    No Results Posted as of Oct 21, 2021