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Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota

The Effect of Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota and Gastrointestinal Function Recovery in Living Donor Hepatectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04079673
Enrollment
60
Registered
2019-09-06
Start date
2019-10-19
Completion date
2022-07-31
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Living Donor Hepatectomy

Keywords

epidural anesthesia, microbiota

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.

Interventions

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

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Microbiota analysisone month16S metagenomic sequence processing

Secondary

MeasureTime frameDescription
LPS-binding proteinone monthLPS-binding protein(mcg/mL)
Intestinal fatty acid binding proteinone monthIntestinal fatty acid binding protein(ng/mL)
IgAone monthIgA(mcg/mL)
IL-6one monthIL-6(ng/mL)
I-FEED scoringone weekI-FEED scoring system for postoperative gastrointestinal function: 1. Intake(score): tolerating oral diet(0), limited tolerance(1), complete Intolerance(3) 2. Feeling nauseated(score): none(0), responsive to treatment(1), resistant to treatment(3) 3. Emesis(score): none(0), ≧1 episode of low volume(\<100mL) and none bilious(1), ≧1 episode of high volume(\>100mL) or bilious(3) 4. Exam(score): no distension(0), distension without tympany(1), significant distension with tympany(3) 5. 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

Countries

Taiwan

Contacts

Primary ContactKuang-Cheng Chan, M.D.,PhD
jkjchan@gmail.com+886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026