Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy (MANTRA)
Efficacy of Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy: Impact on Recovery and Early Hospital Discharge.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: DIANA VERNETTA, MD
- Telefonní číslo: 0034934169700
- E-mail: dvernetta@fundacio-puigvert.es
Studijní místa
-
-
BARCELONA
-
Barcelona, BARCELONA, Španělsko, 08025
- Fundacio Puigvert
-
Kontakt:
- DIANA VERNETTA, MD
- Telefonní číslo: 0034934169700
- E-mail: dvernetta@fundacio-puigvert.es
-
Kontakt:
- Silvia Mateu, MD
- Telefonní číslo: 0034 934169700
- E-mail: smateu@fundacio-puigvert.es
-
Vrchní vyšetřovatel:
- DIANA VERNETTA, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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 |
|
Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change hospital admission time and earlier discharge
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Post surgery pain
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: From start surgery to end surgery
|
Compare the duration of surgery in hours
|
From start surgery to end surgery
|
|
Perioperative complications
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: DIANA VERNETTA, MD, FUNDACIO PUIGVERT IUNA
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- FP2026/01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Multimodal anesthesia
-
Consorci Sanitari de TerrassaBroomx Technologies; Suara Serveis SCCLAktivní, ne náborChudoba | Sociální izolace u starších dospělýchŠpanělsko
-
University of MalagaAndaluz Health ServiceDokončeno