Microsurgical Free FlapsNCT01905501
Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial
A study testing Balanced anesthesia and Total intravenous anesthesia in people with Microsurgical Free Flaps, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Microsurgical Free Flaps
- What is being tested?
- Balanced anesthesia and Total intravenous anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Feb 2015
- Phase
- Interventional
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II
Who cannot join
- Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.
This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. The investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.
- Conditions
- Microsurgical Free Flaps
- Being tested
- Balanced anesthesia, Total intravenous anesthesia
- Keywords
- Balanced anesthesia, Inhalation anesthesia, Reperfusion injury, Microsurgical Free flap
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced anesthesiaDrug
Also called Inhalation anesthesia
Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml
Total intravenous anesthesiaDrug
Also called TIVA-TCI
Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia | Active comparator | Total intravenous anaesthesia Receives: Drug: Total intravenous anesthesia |
| Balanced anesthesia | Experimental | Not described Receives: Drug: Balanced anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
continuous tissue oximetry (NIRS)
Measured: 20 hours
Secondary outcomes (2)
Biochemical Markers
Measured: Preoperative and 24 hours post operative
Lactate Clearance
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microsurgical Free FlapsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, Regina Elena Cancer Institute
- Investigators
- Ester Forastiere, M.D., Principal investigator, Regina Elena CI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905501
- Sponsor's protocol ID
- Versione 02.01.2013
- Status last verified
- Apr 2016
- First submitted
- 18 Jul 2013
- Last updated
- 7 Apr 2016
- Results posted
- No
Publications
Claroni C, Torregiani G, Covotta M, Sofra M, Scotto Di Uccio A, Marcelli ME, Naccarato A, Forastiere E. Protective effect of sevoflurane preconditioning on ischemia-reperfusion injury in patients undergoing reconstructive plastic surgery with microsurgical flap, a randomized controlled trial. BMC Anesthesiol. 2016 Aug 22;16(1):66. doi: 10.1186/s12871-016-0230-1.
PubMed 27549313
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01905501
- Acronym / sponsor ID
- Versione 02.01.2013
- Conditions
- Microsurgical Free Flaps
- Keywords
- Balanced anesthesia, Inhalation anesthesia, Reperfusion injury, Microsurgical Free flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Jul 2013 (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.
This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. The investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia | Active comparator | Drug: Total intravenous anesthesiaTotal intravenous anaesthesia |
| Balanced anesthesia | Experimental | Drug: Balanced anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II
Key exclusion criteria (1 listed)
- Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balanced anesthesiaAlso: Inhalation anesthesiaEt-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml | Drug | Balanced anesthesia |
| Total intravenous anesthesiaAlso: TIVA-TCIPropofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion | Drug | Total intravenous anesthesia |
Primary outcome
continuous tissue oximetry (NIRS)
Time frame: 20 hours
2 secondary outcomes
Biochemical Markers
Time frame: Preoperative and 24 hours post operative
Lactate Clearance
Time frame: 24 hours
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 7 Apr 2016.
- Derived from this study: PubMed 27549313Claroni C, Torregiani G, Covotta M, Sofra M, Scotto Di Uccio A, Marcelli ME, Naccarato A, Forastiere E. Protective effect of sevoflurane preconditioning on ischemia-reperfusion injury in patients undergoing reconstructive plastic surgery with microsurgical flap, a randomized controlled trial. BMC Anesthesiol. 2016 Aug 22;16(1):66. doi: 10.1186/s12871-016-0230-1.
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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.
Ester Forastiere, M.D. principal investigator
Regina Elena CI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balanced anesthesia and Total intravenous anesthesia in people with Microsurgical Free Flaps, run by Regina Elena Cancer Institute at 1 site in Italy.
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 1 inclusion and 1 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 7 Apr 2016. 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 Italy. 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?
continuous tissue oximetry (NIRS) (time frame: 20 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905501, which also lists 1 linked publication.
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 7 Apr 2016.