Breast Cancer
Conditions
Keywords
Admnistration Fat Transfer, Autologous Fat Transfer, Breast Reconstruction, TIVA, volatile anesthesia, stress levels, pain levels
Brief summary
The aim of the present study is to investigate the effect of intravenous anesthetics versus the administration of volatile anesthetics on stress and pain levels during autologous fat transfer for breast reconstruction in a Day Care Center.
Detailed description
The sample of the study will be patients who will have Autologous Fat Transfer for Breast Reconstruction. Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while the DES group (N = 23) volatile anesthetics (desflurane-remifentanil). Specifically, the TIVA group will include patients over 50 years of age with high risk of nausea / vomiting and postoperative delirium, as well as suspicion of malignant hyperthermia. Patients with cardiac and respiratory problems will be included in the DES group. The following data will be collected in the Data Sheet: Patient Demographics (Gender, Age), Body Mass Index (Body Height- Body Weight). Simultaneously, the pain levels will be evaluated by VAS Optical Analogue Scale of VAS 0-10 in PACU, preoperatively and postoperatively, and perioperative pain levels will be assessed with CPOT scale (values 0-8). Stress levels will be evaluated with 3 NAS questions: a. How sad do you feel right now? b. How anxious do you feel right now? and c. How optimistic do you feel right now?. The 3 NAS questions will also be given preoperatively and postoperatively to the ward. The sedation levels will be assessed by RASS scale (values +4 to -5) and the Bispectral Index (BIS). The level of patient's awareness will be assessed by GCS Scale (3 (indicating deep unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised scale)). The presence or absence of nausea / vomiting and the appearance of immediate postoperative complications will be examined. Finally, post-operative stress will be examined with stress biomarkers, salivary ACTH hormone and salivary cortisol hormone.
Interventions
DRUGPropofol
Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while to the DES group (N = 23) volatile anesthetics (desflurane-remifentanil)
Sponsors
Saint Savvas Anticancer Hospital
National and Kapodistrian University of Athens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
TIVA group * patients with American Society of Anesthesiologists (ASA) PHYSICALSTATUS CLASSIFICATION SYSTEM I-III * age \>50 years * high risk of nausea / vomiting * high risk of postoperative delirium * suspicion of malignant hyperthermia. Volatile anesthesia * patients with American Society of Anesthesiologists (ASA) PHYSICALSTATUS CLASSIFICATION SYSTEM I-III * 20-70 years * Patients with cardiac problems * Patients with respiratory problems
Exclusion criteria
•In both groups, the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Εvaluating stress levels | 1 day during hospitalization | Analyzing Cortisol and Adrenocorticotropic hormones levels in salivary samples. Analyzing Cortisol and Adrenocorticotropic hormones levels in salivary samples in patients after breast recostruction in a day care center. These measures will occured in three phases a. preoperatively, b. perioperatively c. in the PACU phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating pain levels between the 2 protocols with scales perioperatively | 1 day during hospitalization | Evaluating perioperative pain levels between the two protocols with scale such as Critical Care Pain Observational Tool (CPOT scale, range 0-8(with a score of 0 = None and 8 = severe pain) ) |
| Evaluating stress levels between the 2 protocols with scales | 1 day during hospitalization | Evaluating perioperative stress levels between the two protocols with scale, such as the self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how sad are you feeling?in two phases: a. preoperatively, b) in PACU |
| Evaluating Patients' Sedation | Perioperatively | Evaluation with Richmond Agitation-Sedation Scale (RASS scale, range +4 to -5, (with a score of -5 = unarousable and +4 = violent, immediate danger for the staff) ). |
| Evaluating pain levels between the 2 protocols with scales in PACU | 1 day during hospitalization | Evaluating perioperative pain levels between the two protocols with scale such as Visual analogu pain scale (VAS, range 0-10, (with a score of 0 = None and 10 = severe pain) ) in PACU |
Countries
Greece
Outcome results
None listed