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NCT Number: NCT07558226

Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy

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.

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Key information

Conditions

Anesthesia Anesthesia and Procedure Related Time Intervals Nephrectomy / Methods

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change hospital admission time and earlier discharge

    Time frame: 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 outcomes

  1. Post surgery pain

    Time frame: 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).

  2. Cumulative consumption of opioids

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

    Compare the cumulative consumption of opioids (morphine equivalents).

  3. Nausea and vomiting

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

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

  4. Early ambulation

    Time frame: From end of surgery to ambulation

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

  5. Oral tolerance

    Time frame: From end of surgery to oral tolerance

    Compare the time in hours from end of surgery to oral tolerance during hospitalization.

  6. Hospital stay

    Time frame: From enrrolment to end of hospital stay

    Compare the time of hospital stay in hours from hospitalization to discharged.

  7. Duration of surgery

    Time frame: From start surgery to end surgery

    Compare the duration of surgery in hours

  8. Perioperative complications

    Time frame: 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.

  9. Readmission or unscheduled consultations

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

    Compare the rate of readmission or unscheduled consultations at 30 days.

  10. Postoperative recovery

    Time frame: 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)

  11. Surgical procedure satisfaction

    Time frame: 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.

  12. Predictive factors for better response to multimodal anesthesia

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

DIANA VERNETTA, MD

CONTACT

[email protected]

0034934169700

Sponsors and collaborators

Lead sponsor

Fundacio Puigvert

Other

Registry information

Official study title

Efficacy of Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy: Impact on Recovery and Early Hospital Discharge.

Acronym: MANTRA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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