Application of Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation Surgery: A Single-Center, Prospective, Randomized Controlled Trails
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Intraoperative Muscle Relaxant Usage
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tubeless Spontaneous Ventilation Anesthesia (TSVA)
干预措施: Tubeless Spontaneous Ventilation Anesthesia (Procedure)
Endotracheal Tube Anesthesia (ETT)
干预措施: Endotracheal Tube Anesthesia (Procedure)
结局指标
主要结局
Intraoperative Muscle Relaxant Usage
时间窗: During surgery (intraoperative intervals, and end of anesthesia)
Total dosage of cisatracurium administered intraoperatively, including induction dose and supplemental doses.
次要结局
- Intraoperative Sedative and Analgesic Drug Usage(During surgery (intraoperative intervals, and end of anesthesia))
- Anesthetic Depth (BIS Monitoring)(During surgery (intraoperative intervals, and end of anesthesia))
- Intraoperative Ventilation Effect(Intraoperative key time points (e.g., post-induction, during operation, end of operation))
- Intraoperative Hemodynamic Stability(During surgery (intraoperative intervals, and end of anesthesia))
- Operation and Anesthesia Duration(During surgery (intraoperative intervals, and end of anesthesia))
- Postoperative Awakening and Recovery Time(Perioperative/Periprocedural)
- Perioperative Pain Scores(up to 24 hours post operatively)
- Postoperative Pulmonary Complications(From intraoperative to three months postoperatively)
- Non-Pulmonary Complications(From intraoperative to three months postoperatively)
- Serum creatinine(Postoperative day 1-90)
- Estimated GFR(Postoperative day 1-90)
- Urine output(up to 7 day post operatively)
研究者
Jianxing He
Clinical Professor
The First Affiliated Hospital of Guangzhou Medical University