Anesthesia, Anesthesia and Procedure Related Time Intervals, Nephrectomy / Methods
Conditions
Keywords
laparoscopic nephrectomy robotic, multimodal anesthesia, early hospital discharge, Anesthesia, Multimodal, Nephrectomy, Robotic
Brief summary
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.
Detailed description
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.
Interventions
DRUGMultimodal 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
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.
Sponsors
Fundacio Puigvert
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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).
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change hospital admission time and earlier discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post surgery pain | 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). |
| Cumulative consumption of opioids | From enrollment to the end of follow up 30 days | Compare the cumulative consumption of opioids (morphine equivalents). |
| Nausea and vomiting | From enrollment to the end of follow up 30 days | Compare the incidence of postoperative nausea and vomiting (PONV). |
| Early ambulation | From end of surgery to ambulation | Compare the time in hours from end of surgery to early ambulation during hospitalization. |
| Oral tolerance | From end of surgery to oral tolerance | Compare the time in hours from end of surgery to oral tolerance during hospitalization. |
| Hospital stay | From enrrolment to end of hospital stay | Compare the time of hospital stay in hours from hospitalization to discharged. |
| Duration of surgery | From start surgery to end surgery | Compare the duration of surgery in hours |
| Perioperative complications | 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. |
| Readmission or unscheduled consultations | From enrollment to the end of follow up 30 days | Compare the rate of readmission or unscheduled consultations at 30 days. |
| Postoperative recovery | 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) |
| Surgical procedure satisfaction | 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. |
| Predictive factors for better response to multimodal anesthesia | 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). |
Countries
Spain
Contacts
CONTACTDIANA VERNETTA, MD
PRINCIPAL_INVESTIGATORDIANA VERNETTA, MD
FUNDACIO PUIGVERT IUNA
Outcome results
None listed