TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction

National and Kapodistrian University of Athens

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04077827

2834

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Total intravenous anesthesia

Experimental group

Description:

The patients will recieve intravenous anesthesia (propofol-remifentanyl) Recommended dosage: Propofol: Induction dosage 1,5-2,5 mg/kg Remifentanyl: Induction dosage 0,5-1μg/min The preservation dosage will depend from patients' body weight, body height and BMI

Treatment:

Drug: Propofol

volatile anesthesia

Experimental group

Description:

The patients will recieve volatile anesthesia (desflurane-remifentanyl) Recommended dosage: Desflurane dosage 6-7 MAC Remifentanyl: Induction dosage 0,5-1μg/min The preservation dosage will depend from patients' body weight, body height and BMI

Treatment:

Drug: Propofol