Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy (MANTRA)
Efficacy of Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy: Impact on Recovery and Early Hospital Discharge.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: DIANA VERNETTA, MD
- Número de telefone: 0034934169700
- E-mail: dvernetta@fundacio-puigvert.es
Locais de estudo
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BARCELONA
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Barcelona, BARCELONA, Espanha, 08025
- Recrutamento
- Fundacio Puigvert
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Contato:
- DIANA VERNETTA, MD
- Número de telefone: 0034934169700
- E-mail: dvernetta@fundacio-puigvert.es
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Contato:
- Silvia Mateu, MD
- Número de telefone: 0034 934169700
- E-mail: smateu@fundacio-puigvert.es
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Investigador principal:
- DIANA VERNETTA, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Multimodal anesthesia
Multimodal anesthesia Balanced general anesthesia. Standardized multimodal analgesia: Paracetamol iv NSAID or COX-2 (if not contraindicated) Magnesium sulfate iv Lidocaine iv Ketamine iv Methadone iv at the beginning surgical incision at low doses TAP block with local anesthetic: Bupivacaine 0.25% 10ml Surgical wound infiltration with local anesthetic: bupivacaine 0.25% 2ml per to knock |
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 surgical incision (single dose). Maintenance: Propofol/sevorane Rocuroni: 0.3mg/kg/h iv Lidocaine: 1-2 mg/Kg/h Ketamine: 0.1-0.2 mg/kg/h Postoperative: Paracetamol: 1g/8h IV Metamizole: 1g/8h iv Rescue opioids if VAS>4: Adolonta or Morphine |
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Comparador Ativo: Conventional anesthesia
Balanced general anesthesia. Standardized conventional analgesia: Paracetamol IV NSAID or COX-2 (if not contraindicated) Analgesia based mainly on systemic opioids. Absence of protocolized regional blocking. |
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 Postoperative: Paracetamol: 1g/8h IV Metamizole: 1g/8h iv Rescue opioids if VAS>4: Adolonta or Morphine. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change hospital admission time and earlier discharge
Prazo: From enrollment to the end of follow up 30 days
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Changes over time in the hospital stay, expressed in hours, will be measured and reported.
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From enrollment to the end of follow up 30 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Post surgery pain
Prazo: Post surgery time 6, 24 and 48 hours.
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Postoperative pain will be assessed using the VAS scale (Visual Analogue Scale) at 6, 24 and 48 hours.
The results will be recorded on a scale of 0 (minimal pain) to 10 (maximum pain).
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Post surgery time 6, 24 and 48 hours.
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Cumulative consumption of opioids
Prazo: From enrollment to the end of follow up 30 days
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Compare the cumulative consumption of opioids (morphine equivalents).
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From enrollment to the end of follow up 30 days
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Nausea and vomiting
Prazo: From enrollment to the end of follow up 30 days
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Compare the incidence of postoperative nausea and vomiting (PONV).
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From enrollment to the end of follow up 30 days
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Early ambulation
Prazo: From end of surgery to ambulation
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Compare the time in hours from end of surgery to early ambulation during hospitalization.
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From end of surgery to ambulation
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Oral tolerance
Prazo: From end of surgery to oral tolerance
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Compare the time in hours from end of surgery to oral tolerance during hospitalization.
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From end of surgery to oral tolerance
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Hospital stay
Prazo: From enrrolment to end of hospital stay
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Compare the time of hospital stay in hours from hospitalization to discharged.
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From enrrolment to end of hospital stay
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Duration of surgery
Prazo: From start surgery to end surgery
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Compare the duration of surgery in hours
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From start surgery to end surgery
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Perioperative complications
Prazo: From enrollment to the end of follow up 30 days
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Compare perioperative complications according to the Clavien-Dindo classification.
It grades complications from I (menor) to V (major), with suffix 'd' for permanent disability.
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From enrollment to the end of follow up 30 days
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Readmission or unscheduled consultations
Prazo: From enrollment to the end of follow up 30 days
|
Compare the rate of readmission or unscheduled consultations at 30 days.
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From enrollment to the end of follow up 30 days
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Postoperative recovery
Prazo: From enrollment to the end of follow up 30 days
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Assess the quality of postoperative recovery using the QoR-15 questionnaire (Quality of Recovery-15).
It consists of 15 items that assess pain, physical comfort, physical independence and emotional state, with a total score ranging from 0 to 150 (the higher the score, the better the recovery)
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From enrollment to the end of follow up 30 days
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Surgical procedure satisfaction
Prazo: From enrollment to the end of follow up 30 days
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Compare the level of general satisfaction with the surgical procedure using a satisfaction questionnaire based on the Likert scale: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied.
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From enrollment to the end of follow up 30 days
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Predictive factors for better response to multimodal anesthesia
Prazo: From enrollment to the end of follow up 30 days
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Determine predictive factors for better response to multimodal anesthesia (e. g.: age report in years, sex (male or female), the ASA (American Society of Anesthesiologists) classification (I-VI), weight and height will be combined to report BMI in kg/m^2, pathological history, nephrectomy, bleeding, perioperative complications).
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From enrollment to the end of follow up 30 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: DIANA VERNETTA, MD, FUNDACIO PUIGVERT IUNA
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- FP2026/01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The investigators and the sponsor will preserve the confidentiality of all patients participating in the clinical trial, in accordance with GCP, and the patient's identity will be kept confidential throughout the trial. Complete affiliation data and written consent will be kept in the investigator's file.
The personal data of the participants will be treated in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (GDPR), and the corresponding Organic Law 3/2018, of 5 December, on the protection of personal data and the guarantee of digital rights. The data collected are only those data strictly necessary for the purposes of this research and will be used exclusively for this purpose.
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CSR
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