Anesthesia on Gut Microbiota and Metabolomics

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04767503
Collaborator
(none)
60
1
2
22.3
2.7

Study Details

Study Description

Brief Summary

Hepatectomies are performed for the treatment of hepatic tumors and livingdonor liver transplantation. The success of liver resection relies on the remnant liver's ability to regenerate after major tissue loss. Despite appropriate liver remnant volume after resection ensures the liver's ability to regenerate, regeneration progresses at variable ratesin patients.

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. 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.

The measurement of small-molecule metabolites has been an integral part of clinical practice including the familiar clinical standards like glucose and creatinine. Metabolomics, however, is able to measure all the metabolites at once. It is possible to get a far more comprehensive picture of what is happening to a patient's physiology or metabolism. Although gut microbiota has been shown to be related to liver disease and liver regeneration. Obtaining a more comprehensive analysis by identifying not only the microbial composition but also the metabolites will be more insightful.

Many routine perioperative aspects of surgical care 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. General anesthesia including volatile anesthetics and opioids, is associated with altered gut microbiota which might in turn affect liver regeneration. In this regard, perioperative care such as anesthesia, is one of the key points for the success of a liver resection. However, which anesthetic method is preferable regarding postoperative outcome or recovery is controversial.

In this study, the study population will include liver tumor resection and living donor hepatectomy. We aimed to 1) identify the relationship of hepatectomy and changes of gut microbiota and metabolomics. 2) investigate the impact of different anesthetic methods on the interaction of gut microbiota and metabolomics.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
The Impact of Different Anesthetic Methods on the Interaction of Gut Microbiota and Metabolomics Following Hepatectomy
Actual Study Start Date :
Feb 20, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Propofol

Maintence of anesthesia during the operation using target control infusion with propofol 1mg/ml with bispetral index(BIS) in the range 40-60.

Drug: Propofol
Maintence of anestheisa with propofol guided by the bispectral index in the range 40-60.

Sham Comparator: Desflurane

Maintence of anesthesia during the operation using inhalational agent desflurane with 0.5 to 1.5 minimal alveolar concentration (MAC) with bispetral index(BIS) in the range 40-60.

Drug: Desflurane
Maintence of anestheisa with desflurane guided by the bispectral index in the range 40-60.

Outcome Measures

Primary Outcome Measures

  1. Microbiota analysis [one month]

    16S metagenomic sequence processing

  2. Metabolomics [one month]

    Changes of metabolites in serum measured by metabolomic mass spectrometry

Secondary Outcome Measures

  1. 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 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Expected to receive hepatic tumor resection in National Taiwan University Hospital, age between 20 and 75 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 Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT04767503
Other Study ID Numbers:
  • 201912148MINB
First Posted:
Feb 23, 2021
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022