Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

Официальное название

Application of Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation Surgery: A Single-Center, Prospective, Randomized Controlled Trails

Обзор

The aim of this clinical trial is to compare the intraoperative use of neuromuscular blocking agents and other anesthetic drugs between tubeless spontaneous ventilation anesthesia (TSVA) and conventional endotracheal intubation (ETT) anesthesia in kidney transplantation. The study will also evaluate the safety, stability, and postoperative recovery associated with TSVA. This trial is designed to address the following questions: * Does TSVA reduce the intraoperative requirement for neuromuscular blocking agents and other anesthetic medications? * Does TSVA improve postoperative outcomes in kidney transplant recipients? * How do the intraoperative safety and stability of TSVA compare with those of ETT anesthesia? Researchers will compare anesthetic drug consumption, intraoperative anesthetic performance, and postoperative recovery outcomes between the TSVA and ETT groups to determine whether TSVA can decrease anesthetic drug use and enhance patient recovery. Participants will: * Undergo a complete preoperative assessment * Receive kidney transplantation under TSVA or ETT anesthesia, with relevant intraoperative data recorded * Receive tubeless postoperative management, with documentation of pain scores, complications, and recovery of graft function * Be followed throughout their lifetime after discharge, providing long-term follow-up information

Вмешательства

• Процедура Tubeless Spontaneous Ventilation Anesthesia
  1. Pre-anesthesia induction: Midazolam 2-3 mg intravenous injection. 2. Laryngeal mask insertion: After spontaneous breathing stabilizes, select an appropriate size laryngeal mask for insertion. 3. Anesthesia depth monitoring: Maintain Bispectral Index (BIS): 40-60. 4. Anesthesia induction and maintenance: Continuous intravenous infusion of Propofol 0.5-2.0 mg/ml (TCL mode), Dexmedetomidine. 5. Analgesia: Sufentanil initial dose, Remifentanil maintenance analgesia. 6. Muscle relaxant: Cisatracur
• Процедура Endotracheal Tube Anesthesia
  1. Pre-anesthesia induction, anesthesia maintenance, and analgesic medication are consistent with the TSVA group. 2. Muscle relaxant: Conventional protocol (induction dose: 0.2 mg/kg, supplemental dose: 4-6 mg every 40 minutes). Additional muscle relaxants are intermittently administered later based on intraoperative muscle relaxation effect and patient response to stimulation. 3. After successful endotracheal intubation, connect to the anesthesia machine for continuous mechanical ventilation (t

Первичные конечные точки

• Intraoperative Muscle Relaxant Usage [Срок оценки: During surgery (intraoperative intervals, and end of anesthesia)]

Вторичные конечные точки (12)

• Intraoperative Sedative and Analgesic Drug Usage [Срок оценки: During surgery (intraoperative intervals, and end of anesthesia)]
• Anesthetic Depth (BIS Monitoring) [Срок оценки: During surgery (intraoperative intervals, and end of anesthesia)]
• Intraoperative Ventilation Effect [Срок оценки: Intraoperative key time points (e.g., post-induction, during operation, end of operation)]
• Intraoperative Hemodynamic Stability [Срок оценки: During surgery (intraoperative intervals, and end of anesthesia)]
• Operation and Anesthesia Duration [Срок оценки: During surgery (intraoperative intervals, and end of anesthesia)]
• Postoperative Awakening and Recovery Time [Срок оценки: Perioperative/Periprocedural]
• Perioperative Pain Scores [Срок оценки: up to 24 hours post operatively]
• Postoperative Pulmonary Complications [Срок оценки: From intraoperative to three months postoperatively]
• Non-Pulmonary Complications [Срок оценки: From intraoperative to three months postoperatively]
• Serum creatinine [Срок оценки: Postoperative day 1-90]
• Estimated GFR [Срок оценки: Postoperative day 1-90]
• Urine output [Срок оценки: up to 7 day post operatively]

Критерии участия

Критерии включения

• No gender restriction, age 18-65 years (including upper and lower limits).
• First-time recipient of citizen organ donation kidney transplantation.
• Type of citizen organ donation must be Category I China (Donation after Brain Death DBD).
• Donor and recipient blood type identical.
• Panel reactive antibody (PRA) results negative within six months preoperatively.
• Body mass index (BMI) <28 kg/m².
• No severe pulmonary ventilation or gas exchange dysfunction, preoperative pulmonary function assessment meets kidney transplantation requirements, preoperative chest CT shows no significant abnormalities.
• No severe arrhythmia (frequent atrial fibrillation or ventricular premature beats), normal cardiac function (ejection fraction > 50%).
• American Society of Anesthesiologists (ASA) physical status classification ≤ III.
• Voluntarily participate in clinical research, fully understand this study and voluntarily sign the informed consent form, and complete all trial procedures.

Критерии исключения

• Combined multi-organ transplantation.
• Previous history of organ transplantation other than kidney.
• Living donor kidney transplantation.
• If one of the two patients receiving a kidney from the same donor does not meet the inclusion criteria, the other patient is also excluded.
• Previous history of mental illness, current psychological assessment does not meet transplantation criteria.
• Other situations where the organ transplant physician assesses the patient as not suitable for transplantation.
• Poor compliance of the recipient or other situations deemed by the researcher as unsuitable for inclusion in the trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07377123 · ES-2025-130-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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