Characterisation of Gut Microbiota in Patients Undergoing Gastrointestinal Surgery With Postoperative Delirium (GIM-POD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Postoperative delirium The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment. |
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.
|
| Non-Postoperative delirium The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment. |
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.
|
Outcome Measures
Primary Outcome Measures
- Characterisation of Gut Microbiota [from baseline to postoperative 72 hours]
this study will characterise gut microbiota in 2 groups of 30 patients
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- ethnic Chinese;
-
- age, 18 to 80 years old;
-
- American Society of Anaesthesiologists (ASA) physical status I or II;
-
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the First Hospital of China Medical University | Shenyang | Liaoning | China | 110001 |
Sponsors and Collaborators
- China Medical University, China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20200319