Clinical trial NCT04077827: TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction
Official title: TIVA Versus Volatile Anesthetics Admnistration on Stress and Pain Levels During Autologous Fat Transfer in Breast Reconstruction, in a Day Care Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Admnistration Fat Transfer
Autologous Fat Transfer
Breast Reconstruction
TIVA
volatile anesthesia
stress levels
pain levels
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Saint Savvas Anticancer Hospital
First posted: 2019-09-04
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria are the opposite of the inclusion criteria

Primary outcomes:
measure: Εvaluating stress levels
timeFrame: 1 day during hospitalization
Secondary outcomes:
measure: Evaluating pain levels between the 2 protocols with scales perioperatively
timeFrame: 1 day during hospitalization
measure: Evaluating stress levels between the 2 protocols with scales
timeFrame: 1 day during hospitalization
measure: Evaluating Patients' Sedation
timeFrame: Perioperatively
measure: Evaluating Patients' Sedation
timeFrame: Perioperatively
measure: Evaluating pain levels between the 2 protocols with scales in PACU
timeFrame: 1 day during hospitalization
measure: Evaluating stress levels between the 2 protocols with scales
timeFrame: 1 day during hospitalization
measure: Evaluating stress levels between the 2 protocols with scales
timeFrame: 1 day during hospitalization
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Saint Savvas" Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Evangelos Konstantinou, RN, PhD
role: STUDY_DIRECTOR
References: