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Anesthesia on Gut Microbiota and Metabolomics

Primary Purpose

Hepatic Tumor Resection

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Propofol
Desflurane
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatic Tumor Resection focused on measuring hepatectomy, microbiota, metabolomics, anesthetic

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of AnesthesiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Propofol

Desflurane

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Microbiota analysis
16S metagenomic sequence processing
Metabolomics
Changes of metabolites in serum measured by metabolomic mass spectrometry

Secondary Outcome Measures

I-FEED scoring
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

Full Information

First Posted
February 16, 2021
Last Updated
March 22, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04767503
Brief Title
Anesthesia on Gut Microbiota and Metabolomics
Official Title
The Impact of Different Anesthetic Methods on the Interaction of Gut Microbiota and Metabolomics Following Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Tumor Resection
Keywords
hepatectomy, microbiota, metabolomics, anesthetic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Maintence of anesthesia during the operation using target control infusion with propofol 1mg/ml with bispetral index(BIS) in the range 40-60.
Arm Title
Desflurane
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Maintence of anestheisa with propofol guided by the bispectral index in the range 40-60.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Maintence of anestheisa with desflurane guided by the bispectral index in the range 40-60.
Primary Outcome Measure Information:
Title
Microbiota analysis
Description
16S metagenomic sequence processing
Time Frame
one month
Title
Metabolomics
Description
Changes of metabolites in serum measured by metabolomic mass spectrometry
Time Frame
one month
Secondary Outcome Measure Information:
Title
I-FEED scoring
Description
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
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Expected to receive hepatic tumor resection in National Taiwan University Hospital, age between 20 and 75 years old. Exclusion Criteria: Previous use of antibiotics within four weeks. Previous gastrointestinal surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuang-Cheng Chan, M.D.,PhD.
Phone
+886-2-23123456
Ext
62158
Email
jkjchan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuang-Cheng Chan, M.D.,PhD.
Organizational Affiliation
Department of Anesthesiology, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuang-Cheng Chan, M.D.,PhD
Phone
+886-2-23123456
Ext
62158

12. IPD Sharing Statement

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Anesthesia on Gut Microbiota and Metabolomics

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