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Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy (MANTRA)

2026年6月29日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • スペイン
    • BARCELONA
      • Barcelona、BARCELONA、スペイン、08025

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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
薬：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
アクティブコンパレータ：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.
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change hospital admission time and earlier discharge
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Post surgery pain
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From start surgery to end surgery
Compare the duration of surgery in hours
From start surgery to end surgery
Perioperative complications
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Fundacio Puigvert

捜査官

  • 主任研究者：DIANA VERNETTA, MD、FUNDACIO PUIGVERT IUNA

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月2日

一次修了 (推定)

2027年11月30日

研究の完了 (推定)

2027年11月30日

試験登録日

最初に提出

2026年4月10日

QC基準を満たした最初の提出物

2026年4月23日

最初の投稿 (実際)

2026年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月1日

QC基準を満たした最後の更新が送信されました

2026年6月29日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • FP2026/01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

It will be published

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • CSR

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いいえ

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いいえ

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