Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy

NCT07558226 | Not Yet Recruiting DMC

• 1 other identifier: FP2026/01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Nephrectomy / Methods; Anesthesia and Procedure Related Time Intervals

Keywords

laparoscopic nephrectomy robotic; multimodal anesthesia; early hospital discharge; Anesthesia; Multimodal; Nephrectomy; Robotic

Outcome Measures

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.

  From enrollment to the end of follow up 30 days

Secondary Outcomes (12)

• Post surgery pain

  Post surgery time 6, 24 and 48 hours.

• Cumulative consumption of opioids

  From enrollment to the end of follow up 30 days

• Nausea and vomiting

  From enrollment to the end of follow up 30 days

• Early ambulation

  From end of surgery to ambulation

• Oral tolerance

  From end of surgery to oral tolerance

Study Arms (2)

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

Drug: Multimodal anesthesia

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.

Drug: Conventional anesthesia

Interventions

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

Multimodal anesthesia

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.

Conventional anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio Puigvert: lead

Study Sites (1)

Fundacio Puigvert

Barcelona, BARCELONA, 08025, Spain

Location

Study Officials

• DIANA VERNETTA, MD

  FUNDACIO PUIGVERT IUNA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DIANA VERNETTA, MD

CONTACT

0034934169700; dvernetta@fundacio-puigvert.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 30, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: IPD and supporting information will be available after publication (not end date)
• Access Criteria: It will be published

Locations

ES (1)