Microvascular Breast Flap in Plastic Surgery Clinical Trial
| NCT number | NCT01972230 |
| Other study ID # | 17713 |
| Secondary ID | Claudia |
| Status | Completed |
| Phase | N/A |
| First received | October 24, 2013 |
| Last updated | April 6, 2016 |
| Start date | January 2013 |
| Verified date | April 2016 |
| Source | Regina Elena Cancer Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 128 |
| Est. completion date | |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - age > 18 yr - ASA (American Society of Anesthesiology) I-II Exclusion Criteria: - Known unusual reaction to anesthetic drugs - Evaluation of anesthesia increased risk for malignant hyperthermia. - History of vascular disease. - History of bleeding diathesis. - Tabagism |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Regina Elena Cancer Institute | Rome | RM |
| Lead Sponsor | Collaborator |
|---|---|
| Regina Elena Cancer Institute |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously. | 24 hours from the end of intervention | No |