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Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy

ConditionsAnesthesiaAnesthesia and Procedure Related Time IntervalsNephrectomy / Methods
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacio Puigvert

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Multimodal anesthesiaActive comparator 1 intervention
Group B: Conventional anesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change hospital admission time and earlier discharge

Changes over time in the hospital stay, expressed in hours, will be measured and reported.

Time frame
From enrollment to the end of follow up 30 days

Secondary outcomes

1

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).

Time frame
Post surgery time 6, 24 and 48 hours.
2

Cumulative consumption of opioids

Compare the cumulative consumption of opioids (morphine equivalents).

Time frame
From enrollment to the end of follow up 30 days
3

Nausea and vomiting

Compare the incidence of postoperative nausea and vomiting (PONV).

Time frame
From enrollment to the end of follow up 30 days
4

Early ambulation

Compare the time in hours from end of surgery to early ambulation during hospitalization.

Time frame
From end of surgery to ambulation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacio Puigvert

Lead sponsor

Source ClinicalTrials.gov
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