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Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy (MANTRA)

29. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Spania
    • BARCELONA
      • Barcelona, BARCELONA, Spania, 08025

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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
Legemiddel: 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
Aktiv komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change hospital admission time and earlier discharge
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post surgery pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From start surgery to end surgery
Compare the duration of surgery in hours
From start surgery to end surgery
Perioperative complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fundacio Puigvert

Etterforskere

  • Hovedetterforsker: DIANA VERNETTA, MD, FUNDACIO PUIGVERT IUNA

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. mai 2026

Primær fullføring (Antatt)

30. november 2027

Studiet fullført (Antatt)

30. november 2027

Datoer for studieregistrering

Først innsendt

10. april 2026

Først innsendt som oppfylte QC-kriteriene

23. april 2026

Først lagt ut (Faktiske)

30. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • FP2026/01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

It will be published

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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