CClinicalTrials.gg
Status unknownNCT04316910GIM-PODUpdated Oct 25, 2022

Characterisation of Gut Microbiota in Patients Undergoing Gastrointestinal Surgery With Postoperative Delirium (GIM-POD)

An observational study in Postoperative Delirium and Gut Microbiota, sponsored by China Medical University, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by China Medical University, China · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

Read the detailed description

The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

General anesthesia was induced as follows: 0.3 mg kg-1 intravenous (IV) etomidate, 2 mg IV midazolam, 0.4 μg kg-1 IV sufentanil, and 0.2 mg kg-1 IV cisatracurium. Anesthesia was maintained with an end-tidal concentration of 2-3 vol% sevoflurane and 0.2-0.3 μg kg-1h-1 sufentanil to maintain the bispectral index between 40 and 60.

02

Conditions studied

  • Postoperative Delirium
  • Gut Microbiota
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 30 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

China Medical University, China is the lead sponsor of 93 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients Undergoing Gastrointestinal Surgery

Inclusion criteria

    1. ethnic Chinese;
    1. age, 18 to 80 years old;
    1. American Society of Anaesthesiologists (ASA) physical status I or II;
    1. required Gastrointestinal Surgery

Exclusion criteria

Exclusion Criteria:

  • Cognitive difficulties
  • Partial or complete gastrectomy
  • Previous esophageal surgery
  • Previous treated by radiotherapy or 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Postoperative delirium

    The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

    Drug: General anesthetic

  • Non-Postoperative delirium

    The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

    Drug: General anesthetic

Interventions

  • DrugGeneral anesthetic

    General anesthesia was induced as follows: 0.3 mg kg-1 intravenous (IV) etomidate, 2 mg IV midazolam, 0.4 μg kg-1 IV sufentanil, and 0.2 mg kg-1 IV cisatracurium. Anesthesia was maintained with an end-tidal concentration of 2-3 vol% sevoflurane and 0.2-0.3 μg kg-1h-1 sufentanil to maintain the bispectral index between 40 and 60.

06

What researchers measure

Primary outcomes

  1. Characterisation of Gut Microbiota

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

    Time frame: from baseline to postoperative 72 hours

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Study locations

1 site
  • the First Hospital of China Medical University
    Shenyang, Liaoning 110001, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04316910
Lead sponsor
China Medical University, China
Responsible party
Wen-fei Tan (clinical professor, China Medical University, China) — Principal investigator
First posted
Mar 20, 2020
Start date
Jul 19, 2023 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Oct 25, 2022

Study contacts

Wen-fei Tan
Contact
winfieldtan@hotmail.com
83283100 ext. 86-024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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