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

Not yet recruiting

• Conditions: Postoperative Delirium; Gut Microbiota
• Interventions: Drug: General anesthetic

• Registration Number: NCT04316910
• Lead Sponsor: China Medical University, China

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.

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-25
• Study Start: 2023-07-19
• Primary Completion: 2023-12-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postoperative delirium	General anesthetic	The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.
Non-Postoperative delirium	General anesthetic	The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

Primary Outcome Measures

Name	Time	Method
Characterisation of Gut Microbiota	from baseline to postoperative 72 hours	this study will characterise gut microbiota in 2 groups of 30 patients

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China