Anesthesia on Gut Microbiota and Metabolomics

NCT04767503 | Unknown

• 1 other identifier: 201912148MINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Tumor Resection

Keywords

hepatectomy; microbiota; metabolomics; anesthetic

Outcome Measures

Primary Outcomes (2)

• Microbiota analysis

  16S metagenomic sequence processing

  one month

• Metabolomics

  Changes of metabolites in serum measured by metabolomic mass spectrometry

  one month

Secondary Outcomes (1)

• I-FEED scoring

  one week

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Desflurane

SHAM COMPARATOR

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

Interventions

Propofol DRUG

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

Propofol

Desflurane DRUG

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

Desflurane

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expected to receive hepatic tumor resection in National Taiwan University Hospital, age between 20 and 75 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

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Propofol; Desflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Kuang-Cheng Chan, M.D.,PhD.

  Department of Anesthesiology, National 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 23, 2021
• Study Start: February 20, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

TW (1)