Opioid Free Anesthesia: What About Patient Comfort?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- QoR-40
研究概览
简要总结
66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other group an opioid free one. The hypothesis of this study was that opioid free anesthesia improves the postoperative quality of recovery of anesthesia.
详细描述
Opioids used as part of balanced anesthesia have known undesired side effects such as: respiratory depression, post-operative nausea and vomiting, pruritus, difficulty voiding and ileus.
The purpose of this study was to determine whether opioid free anesthesia influences the quality of recovery. A multimodal approach combining ketamine, lidocaine and clonidine was used as an alternative for an opioid based anesthesia.
The hypothesis of this study was that patient comfort and satisfaction level after an opioid free anesthesia would be higher compared to after a more traditional opioid anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Oncological patients undergoing a total mastectomy or lumpectomy associated with a total axillary dissection were screened.
- •Patients with an ASA physical status of II were included.
- •Knowledge of either French, English or Dutch was required.
- •Exclusion criteria were the following:
- •Allergy or contraindications to one of the study drugs, renal failure, hepatic failure, hyperthyroidism, AV block 2 or 3 or severe bradycardia, left ventricular failure, unstable blood pressure, epilepsy and psychiatric disturbance.
排除标准
- 未提供
结局指标
主要结局
QoR-40
时间窗: 24 hours post-operatively
Patient comfort was assessed via the QoR-40 questionnaire 24hours post-operatively.
次要结局
- Post-operative NRS(during 24 hours post-operative)
- Post-operative piritramide consumption(during the first 24 hours post-operative)
研究者
Sarah Saxena
M.D.
Université Libre de Bruxelles