- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316910
Characterisation of Gut Microbiota in Patients Undergoing Gastrointestinal Surgery With Postoperative Delirium (GIM-POD) (GIM-POD)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Wen-fei Tan
- Phone Number: 86-024 83283100
- Email: winfieldtan@hotmail.com
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110001
- The First Hospital of China Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Non-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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterisation of Gut Microbiota
Time Frame: from baseline to postoperative 72 hours
|
this study will characterise gut microbiota in 2 groups of 30 patients
|
from baseline to postoperative 72 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200319
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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