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

NCT ID: NCT03981770

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-01-17

Brief Summary

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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

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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.

Conditions

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Sleep Deprivation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group good sleepers

Duration of sleep was defined as the duration of all Bispectral Index data below 80 in the 12 hours of monitoring (from 18:00pm to 06:00am). Sleeping time are more than four hours.

General anesthesia

Intervention Type DRUG

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.

Group poor sleepers

Duration of sleep was defined as the duration of all Bispectral Index data below 80 in the 12 hours of monitoring (from 18:00pm to 06:00am). Sleeping time are less than four hours.

General anesthesia

Intervention Type DRUG

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.

Interventions

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General 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Wen-fei Tan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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20190607

Identifier Type: -

Identifier Source: org_study_id

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