Impact of Opioid Free Anesthesia on the Complications After DIEPflap Surgery: A Retrospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Number of Patients With One or More Complications
研究概览
简要总结
The Deep Inferior Epigastric Perforator free flap (DIEPflap) involves the transfer of abdominal tissue to the breast using microsurgery. Flap failure is rare today, but is devastating.
Blood flow in a DIEPflap decreases during the first hours. Many anesthetic factors like low cardiac output, hypothermia and surgical stress cause vasoconstriction or thrombosis.
A stable anesthesia during these long procedures improves flap perfusion. Postoperative nausea and vomiting (PONV) is frequent and might have an impact.
Opioid free anesthesia (OFA) reduces PONV. The anti-inflammatory and vasodilator effects of the drugs dexmedetomidine and lidocaine might improve free flap perfusion.
The primary outcome counted all complications. The secondary outcomes were PONV, pain, opioid consumption, skin flap temperature and length of hospital stay.
Patients get according to attending anesthesiologist an opioid or opioid free anesthesia without any randomization but based on availability of competence.
详细描述
The investigators included all patients in the hospital database.belgium who underwent DIEPflap surgery between Jan 2014 and April 2019. All patients entering the hospital provided consent to allow retrospective data analysis without patient identification.
Because patient assignment to an operating day was determined without knowing who would perform the anesthesia on a few exceptions, the choice of opioid free anesthesia (OFA) or opioid anesthesia (OA) in most cases was random. Patients were classified as receiving OFA when no opioids were given pre- or intra- operatively until wound closure. Opioids given after wound closure were counted as post-operative opioids. Patients who received a lower dose of intra-operative opioids by using additives were still classified as OA. Post-operative opioid free analgesia was classified as receiving no opioids after wound closure until discharge from hospital in patients not receiving medium- or long-acting opioids, pre- or intra-operatively.
The method of reaching OFA remained stable since 2014. Dexmedetomidine was given in a first loading dose of 0.3 mcg/kg 15 minutes before induction, a second loading dose of 0.1 mcg/kg at induction followed by an infusion of 0.1 mcg/kg/h for maintenance. Lidocaine is given as a loading dose of 1 mg/kg at induction followed by 1 mg/kg/h for maintenance. A Ketamine loading dose of 0.1 mg/kg is given at induction with an extra bolus of 0.7 mg/kg (or max 50 mg) before incision followed by an infusion of 0.1mg/kg/h.
Post-operative analgesia was further improved by continuing very low doses of dexmedetomidine (0.05 mcg/kg/h), ketamine (0.05 mg/kg/h), and lidocaine (0.5 mg/kg/h) for the first hours (maximum 5 hours) with the possibility of giving a bolus of 10 mg lidocaine, 1 mg ketamine and 1 mcg dexmedetomidine every 15 minutes.
OA was induced with sufentanil (0.1 - 0.3 mcg/kg) and continued with extra boli (0.1 - 0.2 mcg/kg) or a continuous infusion of remifentanil (0.20 - 0.35 mcg/kg/h). Since 2014 more and more additives like clonidine, dexmedetomidine, ketamine and lidocaine were given as a single additive at the induction to reduce the total dose of intraoperative opioid use. Nevertheless these patients were still counted as OA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DIEPflap unilat or bilat woman between 18 and 60 years old-
排除标准
- •allergy to any of the drugs used in anesthesia
结局指标
主要结局
Number of Patients With One or More Complications
时间窗: One month postoperative
number of minor and major complications (CLAVIEN) (DINDOO)
次要结局
- Morphine Used(24 hours postoperative)
- Number of Patients With Post Operative Nausea or Vomiting(24 hours postoperative)
- Postoperative Pain: Visual Analog Scale(24 hours postoperative)
- Skin Temperature(24 hours post operative)
- Length of Hospital Stay(up to two weeks)
研究者
Jan Mulier
chairman dep anesthesiology & Reanimation
AZ Sint-Jan AV
