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NCT Number: NCT07377123

Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

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

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Key information

Conditions

Kidney Transplantation CKD (Chronic Kidney Disease) Stage 5D Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tubeless Spontaneous Ventilation Anesthesia

Procedure
  • Pre-anesthesia induction: Midazolam 2-3 mg intravenous injection.
  • Laryngeal mask insertion: After spontaneous breathing stabilizes, select an appropriate size laryngeal mask for insertion.
  • Anesthesia depth monitoring: Maintain Bispectral Index (BIS): 40-60.
  • Anesthesia induction and maintenance: Continuous intravenous infusion of Propofol 0.5-2.0 mg/ml (TCL mode), Dexmedetomidine.
  • Analgesia: Sufentanil initial dose, Remifentanil maintenance analgesia.
  • 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.
  • 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 Anesthesia

Procedure
  • Pre-anesthesia induction, anesthesia maintenance, and analgesic medication are consistent with the TSVA group.
  • 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.
  • After successful endotracheal intubation, connect to the anesthesia machine for continuous mechanical ventilation (tidal volume 6-8 ml/kg).
  • Anesthesia depth monitoring: Maintain Bispectral Index (BIS): 40-60.
  • 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.

Primary outcomes

  1. Intraoperative Muscle Relaxant Usage

    Time frame: During surgery (intraoperative intervals, and end of anesthesia)

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

Secondary outcomes

  1. Intraoperative Sedative and Analgesic Drug Usage

    Time frame: During surgery (intraoperative intervals, and end of anesthesia)

    Total amount of sedatives (e.g., propofol, dexmedetomidine) and analgesics (e.g., remifentanil, sufentanil).

  2. Anesthetic Depth (BIS Monitoring)

    Time frame: During surgery (intraoperative intervals, and end of anesthesia)

    Bispectral Index (BIS) values to assess adequacy of anesthetic depth, 0-40: Deep sedation or unconscious state (e.g., maintenance phase of general anesthesia); 40-60: Ideal range for general anesthesia (commonly used in surgery); 60-90: Mild to moderate sedation or gradual awakening; 90-100: Fully awake.

  3. Intraoperative Ventilation Effect

    Time frame: Intraoperative key time points (e.g., post-induction, during operation, end of operation)

    Arterial PaO₂:

    Normal PaO2 values: 80-100 mmHg PaO2 60-80 mmHg: Mild hypoxia PaO2 45-60 mmHg: Moderate hypoxia PaO2 < 45 mmHg: Severe hypoxia

    Arterial PaCO₂:

    PaCO₂ 35-45 mmHg, normal value PaCO₂ < 35 mmHg, hypocapnia PaCO₂ > 45 mmHg, hypercapnia

  4. Intraoperative Hemodynamic Stability

    Time frame: During surgery (intraoperative intervals, and end of anesthesia)

    Invasive arterial pressure variability/Blood pressure fluctuations at key time points

  5. Operation and Anesthesia Duration

    Time frame: During surgery (intraoperative intervals, and end of anesthesia)

    This outcome measure is primarily used to record the duration of surgery and anesthesia for each patient, and to compare whether the two anesthesia methods affect the surgical process.

  6. Postoperative Awakening and Recovery Time

    Time frame: Perioperative/Periprocedural

    Time to awakening and recovery of consciousness sufficient for extubation/LMA removal. From end of anesthesia to extubation/LMA removal

  7. Perioperative Pain Scores

    Time frame: up to 24 hours post operatively

    Visual Analog Scale (VAS) Score range: 0-10, a score of 0 indicates no pain, while a higher score indicates a greater degree of pain.

    Prince-Henry Score (thoracoabdominal pain) Score range: 0-4 0: No pain when coughing

    • Pain when coughing
    • No pain at rest, pain when taking deep breaths
    • Mild pain at rest, tolerable
    • Severe pain at rest, unbearable

  8. Postoperative Pulmonary Complications

    Time frame: From intraoperative to three months postoperatively

    Hypoxemia, Atelectasis, Pneumonia, Respiratory distress, etc.

  9. Non-Pulmonary Complications

    Time frame: From intraoperative to three months postoperatively

    Hoarseness, Vocal cord paralysis, Nausea/vomiting, Arrhythmia, Delirium, etc.

  10. Serum creatinine

    Time frame: Postoperative day 1-90

    Unit: μmol/L

  11. Estimated GFR

    Time frame: Postoperative day 1-90

    Male Ccr = [(140 - age) × weight (kg)] / [0.818 × Scr (umol/L)] Female Ccr = [(140 - age) × weight (kg)] / [0.818 × Scr (umol/L)]*0.85

  12. Urine output

    Time frame: up to 7 day post operatively

    24-hour total urine output

Sponsors and collaborators

Lead sponsor

Jianxing He

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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