AnesthesiaNCT01021228
Preconditioning Volatile Anesthesia in Liver Surgery
An observational study of Anesthesia, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 257 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients were included undergoing any type of liver resection with inflow occlusion for benign as well as malign diseases between January first, 2005 and December 31, 2007 in a single tertiary care center
Who may be able to join
- > 18 years
- benign and malign disease
- any type of liver surgery
- inflow occlusion during the liver surgery
Who cannot join
- < 18 years
- participation on other interventional and treatment randomized controlled trials,
- trauma of the liver
- liver cirrhosis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universtiy Hospital of Zurich, Department of Visceral and Transplantation Surgery
Zurich, Canton of Zurich, 8091
About this study
Official title: Preconditioning is Indeed Protective
The purpose of this study is to compare the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.
Read the detailed description
Comparing the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.
- Conditions
- Anesthesia
- Keywords
- Liver resection, Continuous volatile anesthesia, Continuous intravenous anesthesia, Preconditioning volatile anesthesia, Comparing three groups of anesthesia during the liver surgery according to their benefit on liver and outcome.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group1 | continuous volatile anesthesia (sevoflurane) during the liver resection | |
| group2 | continuous intravenous anesthesia (propofol) during the liver resection | |
| group3 | preconditioning volatile anesthesia (sevoflurane) 30 minutes before ischemia (inflow occlusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak ALT and AST levels representing the ischemia-reperfusion injury
Measured: post-operative
Secondary outcomes (1)
length of hospital stay, length of ICU stay, blood loss and morbidity (post-operative complications)
Measured: post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Ksenija Slankamenac, med. pract, Principal investigator, Departement of Visceral and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021228
- Sponsor's protocol ID
- StV 18-2008
- Status last verified
- Nov 2009
- First submitted
- 25 Nov 2009
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preconditioning is Indeed Protective
- ClinicalTrials.gov ID
- NCT01021228
- Acronym / sponsor ID
- StV 18-2008
- Conditions
- Anesthesia
- Keywords
- Liver resection, Continuous volatile anesthesia, Continuous intravenous anesthesia, Preconditioning volatile anesthesia, Comparing three groups of anesthesia during the liver surgery according to their benefit on liver and outcome.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.
Detailed description
Comparing the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group1 | – | –continuous volatile anesthesia (sevoflurane) during the liver resection |
| group2 | – | –continuous intravenous anesthesia (propofol) during the liver resection |
| group3 | – | –preconditioning volatile anesthesia (sevoflurane) 30 minutes before ischemia (inflow occlusion) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients were included undergoing any type of liver resection with inflow occlusion for benign as well as malign diseases between January first, 2005 and December 31, 2007 in a single tertiary care center
Key inclusion criteria (4 listed)
- > 18 years
- benign and malign disease
- any type of liver surgery
- inflow occlusion during the liver surgery
Key exclusion criteria (4 listed)
- < 18 years
- participation on other interventional and treatment randomized controlled trials,
- trauma of the liver
- liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peak ALT and AST levels representing the ischemia-reperfusion injury
Time frame: post-operative
1 secondary outcome
length of hospital stay, length of ICU stay, blood loss and morbidity (post-operative complications)
Time frame: post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ksenija Slankamenac, med. pract principal investigator
Departement of Visceral and Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak ALT and AST levels representing the ischemia-reperfusion injury (time frame: post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2009.