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Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery

Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03981770
Enrollment
33
Registered
2019-06-11
Start date
2019-09-01
Completion date
2020-01-17
Last updated
2020-01-28

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

Conditions

Sleep Deprivation

Brief summary

The study is a case-controlled observational trial. Forty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the lung microbiota in patients treated with thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Detailed description

The study is a case-controlled observational trial. Forty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the lung microbiota in patients treated with thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Interventions

DRUGGeneral anesthesia

For maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml. Remifentanil (0.2-0.5 μg/kg/min) was given to all patients during the operation.

Sponsors

China Medical University, China
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ethnic Chinese; * age, 18 to 65 years old; * American Society of Anaesthesiologists (ASA) physical status I or II

Exclusion criteria

* Cognitive difficulties * Affiliated with the Social Security System * Partial or complete gastrectomy * Previous esophageal surgery * Inability to conform to the study's requirements * Deprivation of a right to decide by an administrative or juridical entity * Ongoing participation or participation in another study \<1 month ago

Design outcomes

Primary

MeasureTime frameDescription
gut microbiotathe first postoperative nightthis study will characterise the gut microbiota in 2 groups of 30 patients.

Secondary

MeasureTime frameDescription
Bispectral index datathe first postoperative nightthis study will characterise the Bispectral index data in 2 groups of 30 patients
plasma kynurenine concentrationsbaseline and the first postoperative nightthis study will characterise the plasma kynurenine concentrations in 2 groups of 30 patients

Countries

China

Outcome results

None listed

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