NCT03985735

Brief Summary

The study is a case-controlled observational trial. Sixty 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 gut and lung microbiota in patients with lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 7, 2019

Last Update Submit

June 18, 2020

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • lung and gut microbiota

    this study will characterise the lung and gut microbiota in 2 groups of 30 patients

    from baseline to postoperative 72 hours

Secondary Outcomes (2)

  • Bispectral index data

    the first postoperative night

  • plasma kynurenine concentrations

    baseline and the first postoperative night

Study Arms (2)

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 20:00pm to 06:00am). Sleeping time are more than six hours.

Drug: General anesthesia

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 20:00pm to 06:00am). Sleeping time are less than two hours.

Drug: General anesthesia

Interventions

General anesthesiaDRUG

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. Additional cisatracurium （0.05 mg/kg）and fentanyl (30-50 μg at the end of surgery) were used as needed, in accordance with the clinical requirements.

Group good sleepersGroup poor sleepers

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data.

You may qualify if:

  • \. ethnic Chinese;
  • \. age, 18 to 75 years old;
  • \. American Society of Anaesthesiologists (ASA) physical status I or II;
  • \. required VATS for lung surgery and one lung ventilation .

You may not qualify if:

  • Cognitive difficulties
  • Partial or complete gastrectomy
  • Previous esophageal surgery
  • Previous treated by radiotherapy or surgery
  • Inability to conform to the study's requirements
  • body mass index exceeding 30 kg/m2
  • Deprivation of a right to decide by an administrative or juridical entity
  • Ongoing participation or participation in another study \<1 month ago
  • preoperative Pittsburgh Sleep Quality Index global scores higher than 6
  • recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 14, 2019

Study Start

August 1, 2019

Primary Completion

December 31, 2019

Study Completion

January 20, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Locations

CN(1)