- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267786
The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery
December 28, 2010 updated by: Aretaieio Hospital
The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic function after ischemic/reperfusion injury and the sequence influence on renal and cardiovascular systems.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Georgios P Fragulidis, MD
- Phone Number: +30 6072910955
- Email: gfragulidis@aretaieio.uoa.gr
Study Contact Backup
- Name: Aikaterini D Melemeni, MD, DESA
- Phone Number: +30 6946194817
- Email: amelemeni@med.uoa.gr
Study Locations
-
-
Attica
-
Athens, Attica, Greece, 115 28
- Recruiting
- Aretaieio Hospital
-
Principal Investigator:
- Georgios P Fragulidis, MD
-
-
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
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing liver surgery
Exclusion Criteria:
- ASA IV, Cardiovascular diseases
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sevoflurane
1MAC intraoperatively
|
hepatectomy
|
Active Comparator: desflurane
1 MAC intraoperatively
|
hepatectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxidotic stress after hepatectomy.
Time Frame: 5 d postop.
|
Perioperative liver and renal biopsies and follow up with liver renal function tests plus intraoperative and postoperative cardiovascular monitoring
|
5 d postop.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver and renal dysfunction
Time Frame: 5 d
|
liver and renal impairment due to ischemic injury
|
5 d
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Georgios P Fragulidis, MD, Areataieio Hospital
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
December 1, 2010
Primary Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
December 28, 2010
First Submitted That Met QC Criteria
December 28, 2010
First Posted (Estimate)
December 29, 2010
Study Record Updates
Last Update Posted (Estimate)
December 29, 2010
Last Update Submitted That Met QC Criteria
December 28, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AnesthSurg1
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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