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Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy (MANTRA)

29 juin 2026 mis à jour par: Fundacio Puigvert

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Espagne
    • BARCELONA
      • Barcelona, BARCELONA, Espagne, 08025

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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
Médicament: 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 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
Comparateur actif: 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.
Médicament: 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

Postoperative:

Paracetamol: 1g/8h IV Metamizole: 1g/8h iv Rescue opioids if VAS>4: Adolonta or Morphine.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change hospital admission time and earlier discharge
Délai: 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.
From enrollment to the end of follow up 30 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Post surgery pain
Délai: Post surgery time 6, 24 and 48 hours.
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).
Post surgery time 6, 24 and 48 hours.
Cumulative consumption of opioids
Délai: From enrollment to the end of follow up 30 days
Compare the cumulative consumption of opioids (morphine equivalents).
From enrollment to the end of follow up 30 days
Nausea and vomiting
Délai: From enrollment to the end of follow up 30 days
Compare the incidence of postoperative nausea and vomiting (PONV).
From enrollment to the end of follow up 30 days
Early ambulation
Délai: From end of surgery to ambulation
Compare the time in hours from end of surgery to early ambulation during hospitalization.
From end of surgery to ambulation
Oral tolerance
Délai: From end of surgery to oral tolerance
Compare the time in hours from end of surgery to oral tolerance during hospitalization.
From end of surgery to oral tolerance
Hospital stay
Délai: From enrrolment to end of hospital stay
Compare the time of hospital stay in hours from hospitalization to discharged.
From enrrolment to end of hospital stay
Duration of surgery
Délai: From start surgery to end surgery
Compare the duration of surgery in hours
From start surgery to end surgery
Perioperative complications
Délai: From enrollment to the end of follow up 30 days
Compare perioperative complications according to the Clavien-Dindo classification. It grades complications from I (menor) to V (major), with suffix 'd' for permanent disability.
From enrollment to the end of follow up 30 days
Readmission or unscheduled consultations
Délai: From enrollment to the end of follow up 30 days
Compare the rate of readmission or unscheduled consultations at 30 days.
From enrollment to the end of follow up 30 days
Postoperative recovery
Délai: From enrollment to the end of follow up 30 days
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)
From enrollment to the end of follow up 30 days
Surgical procedure satisfaction
Délai: From enrollment to the end of follow up 30 days
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.
From enrollment to the end of follow up 30 days
Predictive factors for better response to multimodal anesthesia
Délai: From enrollment to the end of follow up 30 days
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).
From enrollment to the end of follow up 30 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fundacio Puigvert

Les enquêteurs

  • Chercheur principal: DIANA VERNETTA, MD, FUNDACIO PUIGVERT IUNA

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 mai 2026

Achèvement primaire (Estimé)

30 novembre 2027

Achèvement de l'étude (Estimé)

30 novembre 2027

Dates d'inscription aux études

Première soumission

10 avril 2026

Première soumission répondant aux critères de contrôle qualité

23 avril 2026

Première publication (Réel)

30 avril 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • FP2026/01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

IPD and supporting information will be available after publication (not end date)

Critères d'accès au partage IPD

It will be published

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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