Efficacy of Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy: Impact on Recovery and Early Hospital Discharge.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change hospital admission time and earlier discharge
研究概览
简要总结
It is a prospective, randomized, controlled and superiority clinical trial, with the objective of comparing the effectiveness of multimodal anesthesia versus conventional anesthesia in patients undergoing oncological robotic nephrectomy within a short-stay surgery program (SSA). The effect of no specific drug will be evaluated, but rather the anesthetic approach ologies of surgical patients. The clinical trial will be carried out in a third-level university hospital, between the first half of 2026 and the second half of 2027 and, after approval by the corresponding Clinical Research Ethics Committee.
详细描述
Prospective, randomized, controlled clinical trial to evaluate whether multimodal anesthesia allows for early hospital discharge (reduce 24-hour admission) compared to conventional anesthesia in oncological robotic nephrectomies; both according to usual practice. The effect of no specific drug will be evaluated, but rather the anesthetic approach pologies of surgical patients. It will be enrolled 80 patients. Patients will be randomized 1:1 using a computer-generated sequence into: Group A: multimodal anesthesia vs Group B: conventional anesthesia.
Main objective is to demonstrate the superiority of multimodal anesthesia over conventional anesthesia in patients undergoing robotic laparoscopic nephrectomy within a short-stay surgical program, in terms of reducing hospital admission time and earlier discharge. To demonstrate that multimodal anesthesia allows a reduction in hospital admission time allowing for early discharge.
Estimated duration of the study is 18 months. This involves collecting data from preoperative to 30 days post-surgery from patients undergoing oncological robotic nephrectomy.
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, Investigator)
盲法说明
Patients will be randomly assigned in a 1:1 ratio to one of the two study groups using a computer-generated randomization sequence. Due to the nature of the anesthetic intervention, blinding of the anesthetic team is not possible. However, the professionals responsible for the assessment of postoperative pain and the collection of clinical data will remain blind to the assigned group (response-blinded evaluators).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years.
- •Indication for elective oncological robotic partial or radical nephrectomy.
- •ASA classification I-III.
- •Candidates for short-stay surgery according to institutional protocol.
- •Signed informed consent.
排除标准
- •Chronic opioid use. Defined as continuous opioid use during the 3 months prior to surgery
- •Uncontrolled chronic pain. Defined as chronic pain not adequately controlled with usual treatment during the 3 months prior to surgery.
- •Contraindications to NSAIDs, regional anesthesia, or drugs of the multimodal protocol.
- •Advanced renal failure (GFR <30 ml/min) at the preanesthetic visit.
结局指标
主要结局
Change hospital admission time and earlier discharge
时间窗: From enrollment to the end of follow up 30 days
Changes over time in the hospital stay, expressed in hours, will be measured and reported.
次要结局
- Duration of surgery(From start surgery to end surgery)
- Hospital stay(From enrrolment to end of hospital stay)
- Post surgery pain(Post surgery time 6, 24 and 48 hours.)
- Cumulative consumption of opioids(From enrollment to the end of follow up 30 days)
- Nausea and vomiting(From enrollment to the end of follow up 30 days)
- Early ambulation(From end of surgery to ambulation)
- Oral tolerance(From end of surgery to oral tolerance)
- Perioperative complications(From enrollment to the end of follow up 30 days)
- Readmission or unscheduled consultations(From enrollment to the end of follow up 30 days)
- Postoperative recovery(From enrollment to the end of follow up 30 days)
- Surgical procedure satisfaction(From enrollment to the end of follow up 30 days)
- Predictive factors for better response to multimodal anesthesia(From enrollment to the end of follow up 30 days)