Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy

Официальное название

Efficacy of Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy: Impact on Recovery and Early Hospital Discharge.

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Multimodal anesthesia
  Administration of multimodal anesthesia in patients randomized to this arm and undergoing oncological robotic nephrectomies according to usual practice. Premedication: Midazolam: 1-2mg Ondansetron: 4-8mg IV Dexamethasone: 4-8mg IV +/-Scopolamine (patients high risk PONV) iv Magnesi Sulfate: 30-50mg/Kg iv Induction: Fentanyl: 1mcg/kg iv Propofol: 1-2mg/Kg iv Rocuroni: 0.3mg/kg iv Lidocaine: 1.1.5mg/Kg iv bolus Ketamine: 0.25-0.5mg/Kg Methadone: 0.5-0.1mg/kg IV at the beginning of the surgica
• Препарат Conventional anesthesia
  Administration of conventional anesthesia in patients randomized to this arm and undergoing oncological robotic nephrectomies according to usual practice. Premedication: Midazolam: 1-2mg Ondansetron: 4-8 mg IV Dexamethasone: 4-8 mg IV +/-Scopolamine (patients high risk PONV) iv Induction: Fentanyl: 1mcg/kg iv Propofol: 1-2mg/kg iv Rocuroni: 0.3mg/kg iv Maintenance: Propofol/sevorane Rocuroni: 0.3mg/kg/h iv Remifentanil: 0.05-0.2 mcg/Kg/h Methadone: 1-1.5mg/kg IV at the end of surgery Pos

Первичные конечные точки

• Change hospital admission time and earlier discharge [Срок оценки: From enrollment to the end of follow up 30 days]

Вторичные конечные точки (12)

• Post surgery pain [Срок оценки: Post surgery time 6, 24 and 48 hours.]
• Cumulative consumption of opioids [Срок оценки: From enrollment to the end of follow up 30 days]
• Nausea and vomiting [Срок оценки: From enrollment to the end of follow up 30 days]
• Early ambulation [Срок оценки: From end of surgery to ambulation]
• Oral tolerance [Срок оценки: From end of surgery to oral tolerance]
• Hospital stay [Срок оценки: From enrrolment to end of hospital stay]
• Duration of surgery [Срок оценки: From start surgery to end surgery]
• Perioperative complications [Срок оценки: From enrollment to the end of follow up 30 days]
• Readmission or unscheduled consultations [Срок оценки: From enrollment to the end of follow up 30 days]
• Postoperative recovery [Срок оценки: From enrollment to the end of follow up 30 days]
• Surgical procedure satisfaction [Срок оценки: From enrollment to the end of follow up 30 days]
• Predictive factors for better response to multimodal anesthesia [Срок оценки: From enrollment to the end of follow up 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Fundacio Puigvert — Barcelona

Идентификаторы

NCT: NCT07558226 · FP2026/01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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