Impact of Multimodal Versus Opioid-Only Anesthesia on Short Term Quality of Recovery After Major Surgery: A Randomized Prospective Single-Center Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions)
研究概览
简要总结
In the context of the ongoing opioid crisis in the USA and Europe, reducing perioperative opioid use is a growing priority. Multimodal anesthesia (MMA) offers a patient-centered alternative to opioid-free anesthesia, combining regional techniques, non-opioid analgesics, and adjunct therapies to enhance pain control while minimizing opioid reliance. By targeting multiple pain pathways, MMA can improve recovery outcomes, reduce side effects, and optimize resource use, representing a potential paradigm shift in perioperative medicine.
This study compares (patient-centered) outcomes after application of MMA (a standardized combination of Magnesium, Ketamine, Lidocain and Dexmedetomidine before and during surgery in combination with opioids) with an opioid based general anesthesia regimen in the context of major surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Existing informed consent
- •German, Italian or French speaking
- •Age 18 or more
- •Planned duration of surgery 60min or more
- •Inpatients and postoperative transfer to PACU or 24h ICU
排除标准
- •Palliative or emergency procedures
- •Reoperation (e.g. 2nd look)
- •Bariatric surgery patients
- •Pregnancy / breastfeeding
- •Adults legally protected
- •Known allergy or contraindication to interventional medication
研究组 & 干预措施
Multimodal anesthesia-group
The intervention consists of the application of a standardized combination of Magnesium, Ketamine, Lidocaine and Dexmedetomidine before and during surgery in combination with opioids (Fentanyl, Methadone, and Hydromorphon) in a non-standardized fashion for perioperative pain control.
干预措施: General anesthesia applying multimodal anesthesia (Procedure)
Opioid based-group
Patients in the control group will be treated with opioids only (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist for perioperative pain control.
干预措施: General anesthesia using conventional opioid-based regimen (Procedure)
结局指标
主要结局
Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions)
时间窗: Postoperative day 1
QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction
次要结局
- Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire)(Postoperative day 2)
- Safety outcome 1b respiratory: airway obstruction needing an intervention(During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Safety outcome 1c respiratory: desaturation(During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Safety outcome 1a respiratory: respiratory rate(During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Safety outcome 2a cardiac: hypotension(During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Safety outcome 2b cardiac: bradycardia(During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Safety outcome 2c cardiac: conduction block(During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Postoperative data 1: pain scores measured by numeric rating scale (NRS)(At arrival and after 6 hours/before leaving post-anesthesia care unit (PACU, expected up to 1 day) or intermediate care (IMC))
- Postoperative data 2: sedation score & delirium rate measured by the Richmond Agitation-Sedation Scale (RASS)(Maximal values during stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Impact on long-term opioid use after hospital discharge(Hospital discharge (expected up to 3 weeks))
- Postoperative data 3: severity of postoperative nausea and vomiting(During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Postoperative data 4: oxygen use(During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day)
- Opioid consumption in the post-operative period(First 48 hours postoperatively)