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

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Delirium, Gut Microbiota

Intervention / Treatment
-----------------
* Drug: General anesthetic


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative delirium<br>The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment. | Drug: General anesthetic<br>* 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.<br>|
| Non-Postoperative delirium<br>The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment. | Drug: General anesthetic<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterisation of Gut Microbiota | this study will characterise gut microbiota in 2 groups of 30 patients | from baseline to postoperative 72 hours |