Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota

NCT04079673 | Unknown

• 1 other identifier: 201812090RINC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Living Donor Hepatectomy

Keywords

epidural anesthesia; microbiota

Outcome Measures

Primary Outcomes (1)

• Microbiota analysis

  16S metagenomic sequence processing

  one month

Secondary Outcomes (5)

• LPS-binding protein

  one month

• Intestinal fatty acid binding protein

  one month

• IgA

  one month

• IL-6

  one month

• I-FEED scoring

  one week

Study Arms (2)

Patient controlled epidural analgesia

ACTIVE COMPARATOR

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

Procedure: Patient controlled epidural analgesia

Intravenous patient controlled analgesia

SHAM COMPARATOR

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

Drug: Intravenous patient controlled analgesia

Interventions

Patient controlled epidural analgesia PROCEDURE

Patient controlled epidural analgesia with marcaine 0.66mg/ml +fentanyl 1.75mcg/ml for postoperative pain control

Also known as: PCEA

Patient controlled epidural analgesia

Intravenous patient controlled analgesia DRUG

Intravenous patient controlled analgesia with morphine 1mg/ml for postoperative pain control

Also known as: IVPCA

Intravenous patient controlled analgesia

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Expected to receive living liver hepatectomy in National Taiwan University Hospital, age between 20 and 55 years old.

You may not qualify if:

• Previous use of antibiotics within four weeks.
• Previous gastrointestinal surgery.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Anesthesiology, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Kuang-Cheng Chan, M.D.,PhD

  Department of Anesthesiology, Natioanal Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-Cheng Chan, M.D.,PhD

CONTACT

+886-2-23123456; jkjchan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: October 19, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 21, 2021

Record last verified: 2020-10

Locations

TW (1)