Microvascular Breast Flap in Plastic SurgeryNCT01972230
Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery
A study testing Sevoflurane and Diprivan + Remifentanil TCI in people with Microvascular Breast Flap in Plastic Surgery, 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 (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion injury in microvascular flap in plastic surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Microvascular Breast Flap in Plastic Surgery
- What is being tested?
- Sevoflurane and Diprivan + Remifentanil TCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Apr 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
- age > 18 yr
- ASA (American Society of Anesthesiology) I-II
Who cannot join
- Known unusual reaction to anesthetic drugs
- Evaluation of anesthesia increased risk for malignant hyperthermia.
- History of vascular disease.
- History of bleeding diathesis.
- Tabagism
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the possible protective effect of anesthetic technique balanced (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion injury in microvascular flap in plastic surgery. The investigators will evaluate the viability of the flap using tissue oximetry monitoring and the level of biochemical markers in a circle at the end of the intervention.
- Being tested
- Sevoflurane, Diprivan + Remifentanil TCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Diprivan + Remifentanil TCIDrug
| Study group | Role | What they receive |
|---|---|---|
| Bilanced group | Experimental | Sevofluorane adjusted to obtain an Et-Sevo of 1.8-2%, for all the time of the surgical procedure.
Remifentanyl TCI adjusted according to protocol to maintain the range of 1-3 ng / ml. Receives: Drug: Sevoflurane |
| TCI group | Active comparator | Propofol 3-4 mg / ml and remifentanyl 1-3 ng / ml according to protocol TCI Receives: Drug: Diprivan + Remifentanil TCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously.
Measured: 24 hours from the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular Breast Flap in Plastic SurgeryStudies 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
- 128 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972230
- Sponsor's protocol ID
- 17713
- Other IDs
- Claudia
- Status last verified
- Apr 2016
- First submitted
- 24 Oct 2013
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 Microvascular Surgery
- ClinicalTrials.gov ID
- NCT01972230
- Acronym / sponsor ID
- 17713
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2015 (actual)
- First posted
- 30 Oct 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 (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion injury in microvascular flap in plastic surgery. The investigators will evaluate the viability of the flap using tissue oximetry monitoring and the level of biochemical markers in a circle at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilanced group | Experimental | Drug: SevofluraneSevofluorane adjusted to obtain an Et-Sevo of 1.8-2%, for all the time of the surgical procedure. Remifentanyl TCI adjusted according to protocol to maintain the range of 1-3 ng / ml. |
| TCI group | Active comparator | Drug: Diprivan + Remifentanil TCIPropofol 3-4 mg / ml and remifentanyl 1-3 ng / ml according to protocol TCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 yr
- ASA (American Society of Anesthesiology) I-II
Key exclusion criteria (5 listed)
- Known unusual reaction to anesthetic drugs
- Evaluation of anesthesia increased risk for malignant hyperthermia.
- History of vascular disease.
- History of bleeding diathesis.
- Tabagism
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 |
|---|---|---|
| Sevoflurane | Drug | Bilanced group |
| Diprivan + Remifentanil TCI | Drug | TCI group |
Primary outcome
tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously.
Time frame: 24 hours from the end of intervention
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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Diprivan + Remifentanil TCI in people with Microvascular Breast Flap in Plastic Surgery, 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 2 inclusion and 5 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?
tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously. (time frame: 24 hours from the end of intervention). 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 7 Apr 2016.