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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04316910
Acronym
GIM-POD
Enrollment
30
Registered
2020-03-20
Start date
2023-07-19
Completion date
2024-09-30
Last updated
2022-10-25

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

Conditions

Gut Microbiota, Postoperative Delirium

Brief 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.

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.

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.

Sponsors

China Medical University, China
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* 1\. ethnic Chinese; * 2\. age, 18 to 80 years old; * 3\. American Society of Anaesthesiologists (ASA) physical status I or II; * 4\. required Gastrointestinal Surgery

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

Design outcomes

Primary

MeasureTime frameDescription
Characterisation of Gut Microbiotafrom baseline to postoperative 72 hoursthis study will characterise gut microbiota in 2 groups of 30 patients

Countries

China

Contacts

Primary ContactWen-fei Tan
winfieldtan@hotmail.com83283100

Outcome results

None listed

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