Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit? Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Postoperative Systemic Inflammatory Response (Platelet Level)
研究概览
简要总结
Opioid Free Anesthesia (OFA) is a multimodal anesthesia and emerging technique that spares the use of opioids and involve other adjuvant anesthetics, which have demonstrated in vitro influence on immunologic and inflammatory response, as well as in metastatic progression. For these reasons we believe that OFA may positively influence in oncologic patients postoperative recovery and in its disease progression.
详细描述
After Local Ethics Committee approval, consecutive consenting patients scheduled for major gynecologic oncologic surgery were included between February 2019 and January 2020 in this observational retrospective study. We Compared OFA to standard technique used in our institution and assessed its effect on Postoperative Systemic Inflammatory Response (SIRS), hospital stay, postoperative complications in the following 2 months, cancer progression and mortality 6 months and 12 months after surgery. OFA protocol consisted of a Total IntraVenous Anaesthesia of Propofol, a Dexmedetomidine infusion of 0,8-1,0 mcg/kg/h, together with 0,2-0,3 mg/kg ketamine and lidocaine 1,5 mg/kg in the first hour of surgery. The standard anaesthetic protocol included opioids (Fentanyl 2mcg/kg at induction, and remifentanyl infusion 0,1-0,2 mcg/kg/min) and volatile agents (sevoflurane or desflurane). Patients in both groups received a regional block when possible, dexamethasone 8 mg at induction and paracetamol 1g plus dexketoprofen 50mg at the end of surgery. Continuous variables were compared using unpaired t-test (or Mann-Whitney U test) and categorical variables by Chi-square test. Statistical significance was set at p < 0.05
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 91 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who had Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced anesthesia with opioids, both combined with regional anesthesia.
排除标准
- •Patients who had Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced anesthesia with opioids, but had later surgery with a different to previous anesthesia technique.
- •Patients who had no later follow up during 12 months in the same Hospital, so we cannot register recurrence.
研究组 & 干预措施
Balanced anesthesia with opioids
Patients who had Major Surgery for gynecologic cancers (cervix, endometrium, ovarian and breast cancer) under balanced anesthesia including opioids between February 2019 and 2020 in Hospital La Paz.
干预措施: Opioid (Drug)
结局指标
主要结局
Postoperative Systemic Inflammatory Response (Platelet Level)
时间窗: 48 hours after surgery
To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level
Postoperative Systemic Inflammatory Response (C-Reactive Protein)
时间窗: 48 hours after surgery
To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level
Postoperative Systemic Inflammatory Response (Leucocytes Ratio)
时间窗: 48 hours after surgery
To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio
次要结局
- Number of Participants with Cancer recurrence after surgery(12 months after surgery)
- Rate of later postoperative complications(3 months after surgery)
- Time spent in the Post-Anesthesia Care Unit (PACU)(30 days after surgery)
- Hospital stay(30 days after surgery)
- Number of patients who Survive 12 months after surgery(12 months after surgery)