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

NCT04316910 | Unknown DMC

• 1 other identifier: 20200319
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• Characterisation of Gut Microbiota

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

  from baseline to postoperative 72 hours

Study Arms (2)

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

General anesthetic DRUG

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.

Non-Postoperative delirium; Postoperative delirium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients Undergoing Gastrointestinal Surgery

You may qualify if:

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

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
• Deprivation of a right to decide by an administrative or juridical entity
• Ongoing participation or participation in another study \<1 month ago

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Anesthetics, General

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Wen-fei Tan

CONTACT

83283100; winfieldtan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 20, 2020
• Study Start: July 19, 2023
• Primary Completion: December 30, 2023
• Study Completion: September 30, 2024
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

CN (1)