- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01617811
Effect of Epidural Anesthesia and Analgesia on Patients' Outcomes After Liver Resection
June 9, 2012 updated by: Chun-Yan Yan, Sir Run Run Shaw Hospital
Effects of Epidural Anesthesia and Analgesia on Postoperative Metabolic, Immune Function and Hemodynamic Changes of Open Liver Resection
The purpose of this study is to analyze the effects of epidural anesthesia and analgesia on intraoperative clinical outcome, postoperative recovery, metabolic changes, and immune functions of the patients receiving open liver resection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- left hemihepatectomy left lateral sectionectomy clinical diagnosis of hepatolithiasis
Exclusion Criteria:
- abnormal coagulation tests diabetes mellitus significant cirrhosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcomes during and after open liver resection
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
intraoperative outcome including operation time, liver resection time, estimated blood loss, urine output, etc during operation. PACU recovery, pain score, liver and gastrointestinal function, hospital stay time,etc assessed. Before operation, right after operation(0), and 3hr, 12hr, 24hr, 72hrs after operation, blood glucose and insulin was measured. |
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cytokine change in perioperation of open liver resection
Time Frame: Before operation, within 5 days after operation
|
Before operation and 0, 3hr, 12hr, 24hr, D3, D5 after operation, serum IL-1β, IFN-γ, IL-4, IL-10 and TGF-β by microassay.
|
Before operation, within 5 days after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (ACTUAL)
December 1, 2008
Study Completion (ACTUAL)
December 1, 2008
Study Registration Dates
First Submitted
June 5, 2012
First Submitted That Met QC Criteria
June 9, 2012
First Posted (ESTIMATE)
June 12, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 12, 2012
Last Update Submitted That Met QC Criteria
June 9, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20120530
- No. 2009R50040 (OTHER_GRANT: Foundation of Science and Technology Department of Zhejiang)
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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