Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

Official title

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

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

Interventions

• Procedure 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
• Procedure 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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07377123 · ES-2025-130-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗