NCT04316910

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• Postoperative Delirium
• Gut Microbiota

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-19
• Primary completion: 2023-12-30
• Completion: 2024-09-30
• First posted: 2020-03-20
• Last updated: 2022-10-25

Locations

1 site across 1 country: China