Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

N/ANot Yet RecruitingNCT07377123

Jianxing He60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Kidney Transplantation

Interventions

Tubeless Spontaneous Ventilation AnesthesiaPROCEDURE

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: Cisatracurium initial dose 2-10 mg, to reduce abdominal muscle tension without excessively suppressing spontaneous breathing. Additional doses may be given during surgery based on the situation. 7. Intraoperative monitoring: Continuous monitoring of ECG, heart rate, invasive blood pressure, SpO₂; intermittent monitoring of end-tidal CO₂, tidal volume, fraction of inspired oxygen during airway patency; regular arterial blood gas analysis.

Endotracheal Tube AnesthesiaPROCEDURE

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 (tidal volume 6-8 ml/kg). 4. Anesthesia depth monitoring: Maintain Bispectral Index (BIS): 40-60. 5. Intraoperative monitoring: Continuous monitoring of ECG, heart rate, invasive blood pressure, SpO₂; intermittent monitoring of end-tidal CO₂, tidal volume, fraction of inspired oxygen during airway patency; regular arterial blood gas analysis.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. No gender restriction, age 18-65 years (including upper and lower limits). 2. First-time recipient of citizen organ donation kidney transplantation. 3. Type of citizen organ donation must be Category I China (Donation after Brain Death DBD). 4. Donor and recipient blood type identical. 5. Panel reactive antibody (PRA) results negative within six months preoperatively. 6. Body mass index (BMI) \<28 kg/m². 7. No severe pulmonary ventilation or gas exchange dysfunction, preoperative pulmonary function assessment meets kidney transplantation requirements, preoperative chest CT shows no significant abnormalities. 8. No severe arrhythmia (frequent atrial fibrillation or ventricular premature beats), normal cardiac function (ejection fraction \> 50%). 9. American Society of Anesthesiologists (ASA) physical status classification ≤ III. 10. Voluntarily participate in clinical research, fully understand this study and voluntarily sign the informed consent form, and complete all trial procedures. Exclusion Criteria: 1. Combined multi-organ transplantation. 2. Previous history of organ transplantation other than kidney. 3. Living donor kidney transplantation. 4. 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. 5. Previous history of mental illness, current psychological assessment does not meet transplantation criteria. 6. Other situations where the organ transplant physician assesses the patient as not suitable for transplantation. 7. Poor compliance of the recipient or other situations deemed by the researcher as unsuitable for inclusion in the trial.

Outcomes

Primary Outcomes

Intraoperative Muscle Relaxant Usage

Total dosage of cisatracurium administered intraoperatively, including induction dose and supplemental doses.