Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

Jianxing He

Status: Not yet enrolling

Conditions: CKD (Chronic Kidney Disease) Stage 5D; Kidney Transplantation

Treatments: Procedure: Endotracheal Tube Anesthesia; Procedure: Tubeless Spontaneous Ventilation Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07377123

ES-2025-130-02

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Tubeless Spontaneous Ventilation Anesthesia (TSVA)

Experimental group

Treatment:

Procedure: Tubeless Spontaneous Ventilation Anesthesia

Endotracheal Tube Anesthesia (ETT)

Active Comparator group

Treatment:

Procedure: Endotracheal Tube Anesthesia