TIVA Versus Volatile Anesthetics Admnistration on Stress and Pain Levels During Autologous Fat Transfer in Breast Reconstruction, in a Day Care Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Εvaluating stress levels
研究概览
简要总结
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.
详细描述
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)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Propofol (Drug)
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
干预措施: Propofol (Drug)
结局指标
主要结局
Εvaluating stress levels
时间窗: 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.
次要结局
- Evaluating pain levels between the 2 protocols with scales perioperatively(1 day during hospitalization)
- Evaluating stress levels between the 2 protocols with scales(1 day during hospitalization)
- Evaluating Patients' Sedation(Perioperatively)
- Evaluating pain levels between the 2 protocols with scales in PACU(1 day during hospitalization)
研究者
Maria Kapritsou
Principal Investigator
National and Kapodistrian University of Athens