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

Postoperative Delirium Clinical Trial

— GIM-POD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04316910
• Other study ID #: 20200319
• Status: Not yet recruiting
• Start date: July 19, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2022
• Source: China Medical University, China
• Contact: Wen-fei Tan
• Phone: 83283100
• Email: winfieldtan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: December 30, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Gut Microbiota
• Postoperative Delirium

Intervention

Drug:
• General 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.

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterisation of Gut Microbiota	this study will characterise gut microbiota in 2 groups of 30 patients	from baseline to postoperative 72 hours