Anesthesia on Gut Microbiota and Metabolomics

The Impact of Different Anesthetic Methods on the Interaction of Gut Microbiota and Metabolomics Following Hepatectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatic Tumor Resection
• Intervention / Treatment: Drug: Propofol; Drug: Desflurane

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kuang-Cheng Chan, M.D.,PhD.; Phone Number: 62158 +886-2-23123456; Email: jkjchan@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • Department of Anesthesiology
    • Contact: Kuang-Cheng Chan, M.D.,PhD; Phone Number: 62158 +886-2-23123456

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota analysis	16S metagenomic sequence processing	one month
Metabolomics	Changes of metabolites in serum measured by metabolomic mass spectrometry	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one week

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (ACTUAL): February 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: anesthetic; microbiota; metabolomics; hepatectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Desflurane
• Other Study ID Numbers: 201912148MINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No