TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
| Laatst geverifieerd: | 01/31/2020 |
| Eerste ingediend: | 08/22/2019 |
| Geschatte inschrijving ingediend: | 09/02/2019 |
| Eerst geplaatst: | 09/03/2019 |
| Laatste update ingediend: | 02/23/2020 |
| Laatste update geplaatst: | 02/24/2020 |
| Werkelijke startdatum van het onderzoek: | 08/31/2019 |
| Geschatte primaire voltooiingsdatum: | 03/29/2020 |
| Geschatte voltooiingsdatum van het onderzoek: | 07/14/2020 |
Conditie of ziekte
Interventie / behandeling
Drug: Propofol
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: Total intravenous anesthesia 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 | |
| Experimental: volatile anesthesia 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 |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 20 Years Naar 20 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| 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 |
Resultaat
Primaire uitkomstmaten
1. Εvaluating stress levels [1 day during hospitalization]
Secundaire uitkomstmaten
1. Evaluating pain levels between the 2 protocols with scales perioperatively [1 day during hospitalization]
2. Evaluating stress levels between the 2 protocols with scales [1 day during hospitalization]
3. Evaluating Patients' Sedation [Perioperatively]
4. Evaluating Patients' Sedation [Perioperatively]
5. Evaluating pain levels between the 2 protocols with scales in PACU [1 day during hospitalization]
6. Evaluating stress levels between the 2 protocols with scales [1 day during hospitalization]
7. Evaluating stress levels between the 2 protocols with scales [1 day during hospitalization]
