AnesthesiaMANTRANCT07558226
Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy
A study testing Multimodal anesthesia and Conventional anesthesia in people with Anesthesia and Anesthesia and Procedure Related Time Intervals, run by Fundacio Puigvert at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Anesthesia and Procedure Related Time Intervals, Nephrectomy / Methods
- What is being tested?
- Multimodal anesthesia and Conventional anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Fundacio Puigvert
Barcelona, BARCELONA, 08025
DIANA VERNETTA, MD, 0034934169700, dvernetta@fundacio-puigvert.es
Silvia Mateu, MD, 0034 934169700, smateu@fundacio-puigvert.es
About this study
Official title: Efficacy of Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy: Impact on Recovery and Early Hospital Discharge.
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.
Read the 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.
- Being tested
- Multimodal anesthesia, Conventional anesthesia
- Keywords
- laparoscopic nephrectomy robotic, multimodal anesthesia, early hospital discharge, Anesthesia, Multimodal, Nephrectomy, Robotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal anesthesiaDrug
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 anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Conventional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change hospital admission time and earlier discharge
Changes over time in the hospital stay, expressed in hours, will be measured and reported.
Measured: From enrollment to the end of follow up 30 days
Secondary outcomes (12)
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).
Measured: Post surgery time 6, 24 and 48 hours.
Cumulative consumption of opioids
Compare the cumulative consumption of opioids (morphine equivalents).
Measured: From enrollment to the end of follow up 30 days
Nausea and vomiting
Compare the incidence of postoperative nausea and vomiting (PONV).
Measured: 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.
Measured: From end of surgery to ambulation
Oral tolerance
Compare the time in hours from end of surgery to oral tolerance during hospitalization.
Measured: From end of surgery to oral tolerance
Hospital stay
Compare the time of hospital stay in hours from hospitalization to discharged.
Measured: From enrrolment to end of hospital stay
Duration of surgery
Compare the duration of surgery in hours
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: From enrollment to the end of follow up 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start2 May 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Puigvert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DIANA VERNETTA, MD, Principal investigator, FUNDACIO PUIGVERT IUNA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558226
- Sponsor's protocol ID
- FP2026/01
- Acronym
- MANTRA
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy: Impact on Recovery and Early Hospital Discharge.
- ClinicalTrials.gov ID
- NCT07558226
- Acronym / sponsor ID
- MANTRA / FP2026/01
- Keywords
- laparoscopic nephrectomy robotic, multimodal anesthesia, early hospital discharge, Anesthesia, Multimodal, Nephrectomy, Robotic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundacio PuigvertUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Multimodal anesthesia | Active comparator | Drug: Multimodal anesthesiaMultimodal 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 |
| Conventional anesthesia | Active comparator | Drug: Conventional anesthesiaBalanced 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal anesthesiaAdministration 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 | Drug | Multimodal anesthesia |
| Conventional anesthesiaAdministration 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. | Drug | Conventional anesthesia |
Primary outcome
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.
12 secondary outcomes
Post surgery pain
Time frame: Post surgery time 6, 24 and 48 hours.
Cumulative consumption of opioids
Time frame: From enrollment to the end of follow up 30 days
Nausea and vomiting
Time frame: From enrollment to the end of follow up 30 days
Early ambulation
Time frame: From end of surgery to ambulation
Oral tolerance
Time frame: From end of surgery to oral tolerance
Hospital stay
Time frame: From enrrolment to end of hospital stay
Duration of surgery
Time frame: From start surgery to end surgery
Perioperative complications
Time frame: From enrollment to the end of follow up 30 days
Readmission or unscheduled consultations
Time frame: From enrollment to the end of follow up 30 days
Postoperative recovery
Time frame: From enrollment to the end of follow up 30 days
Surgical procedure satisfaction
Time frame: From enrollment to the end of follow up 30 days
Predictive factors for better response to multimodal anesthesia
Time frame: From enrollment to the end of follow up 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DIANA VERNETTA, MD principal investigator
FUNDACIO PUIGVERT IUNA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal anesthesia and Conventional anesthesia in people with Anesthesia and Anesthesia and Procedure Related Time Intervals, run by Fundacio Puigvert at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DIANA VERNETTA, MD (0034934169700, dvernetta@fundacio-puigvert.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change hospital admission time and earlier discharge (time frame: From enrollment to the end of follow up 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.