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Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy (MANTRA)

2026년 6월 29일 업데이트: Fundacio Puigvert

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

80

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Multimodal anesthesia

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
의약품: Multimodal 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
활성 비교기: Conventional anesthesia

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.
의약품: Conventional anesthesia

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change hospital admission time and earlier discharge
기간: 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.
From enrollment to the end of follow up 30 days

2차 결과 측정

결과 측정
측정값 설명
기간
Post surgery pain
기간: 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).
Post surgery time 6, 24 and 48 hours.
Cumulative consumption of opioids
기간: From enrollment to the end of follow up 30 days
Compare the cumulative consumption of opioids (morphine equivalents).
From enrollment to the end of follow up 30 days
Nausea and vomiting
기간: From enrollment to the end of follow up 30 days
Compare the incidence of postoperative nausea and vomiting (PONV).
From enrollment to the end of follow up 30 days
Early ambulation
기간: From end of surgery to ambulation
Compare the time in hours from end of surgery to early ambulation during hospitalization.
From end of surgery to ambulation
Oral tolerance
기간: From end of surgery to oral tolerance
Compare the time in hours from end of surgery to oral tolerance during hospitalization.
From end of surgery to oral tolerance
Hospital stay
기간: From enrrolment to end of hospital stay
Compare the time of hospital stay in hours from hospitalization to discharged.
From enrrolment to end of hospital stay
Duration of surgery
기간: From start surgery to end surgery
Compare the duration of surgery in hours
From start surgery to end surgery
Perioperative complications
기간: 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.
From enrollment to the end of follow up 30 days
Readmission or unscheduled consultations
기간: From enrollment to the end of follow up 30 days
Compare the rate of readmission or unscheduled consultations at 30 days.
From enrollment to the end of follow up 30 days
Postoperative recovery
기간: 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)
From enrollment to the end of follow up 30 days
Surgical procedure satisfaction
기간: 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.
From enrollment to the end of follow up 30 days
Predictive factors for better response to multimodal anesthesia
기간: 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).
From enrollment to the end of follow up 30 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fundacio Puigvert

수사관

  • 수석 연구원: DIANA VERNETTA, MD, FUNDACIO PUIGVERT IUNA

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 2일

기본 완료 (추정된)

2027년 11월 30일

연구 완료 (추정된)

2027년 11월 30일

연구 등록 날짜

최초 제출

2026년 4월 10일

QC 기준을 충족하는 최초 제출

2026년 4월 23일

처음 게시됨 (실제)

2026년 4월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 29일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • FP2026/01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

IPD and supporting information will be available after publication (not end date)

IPD 공유 액세스 기준

It will be published

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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