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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal anesthesia | Active Comparator | 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 |
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| Conventional anesthesia | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal anesthesia | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change hospital admission time and earlier discharge | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post surgery pain | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DIANA VERNETTA, MD | Contact | 0034934169700 | dvernetta@fundacio-puigvert.es |
| Name | Affiliation | Role |
|---|---|---|
| DIANA VERNETTA, MD | FUNDACIO PUIGVERT IUNA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacio Puigvert | Recruiting | Barcelona | BARCELONA | 08025 | Spain |
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 and supporting information will be available after publication (not end date)
It will be published
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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.
Group 1: multimodal anesthesia Group 2: conventional anesthesia
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Patients will be randomly assigned in a 1:1 ratio to one of the two study groups using a computer-generated randomization sequence. Due to the nature of the anesthetic intervention, blinding of the anesthetic team is not possible. However, the professionals responsible for the assessment of postoperative pain and the collection of clinical data will remain blind to the assigned group (response-blinded evaluators).
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| Conventional anesthesia | Drug | 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. |
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Compare the cumulative consumption of opioids (morphine equivalents). |
| From enrollment to the end of follow up 30 days |
| Nausea and vomiting | Compare the incidence of postoperative nausea and vomiting (PONV). | From enrollment to the end of follow up 30 days |
| Early ambulation | Compare the time in hours from end of surgery to early ambulation during hospitalization. | From end of surgery to ambulation |
| 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 | Compare the time of hospital stay in hours from hospitalization to discharged. | From enrrolment to end of hospital stay |
| Duration of surgery | Compare the duration of surgery in hours | From start surgery to end surgery |
| Perioperative complications | 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 | Compare the rate of readmission or unscheduled consultations at 30 days. | From enrollment to the end of follow up 30 days |
| Postoperative recovery | 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 | 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 | 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 |