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Kidney TransplantationNCT07377123

Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

A study testing Tubeless Spontaneous Ventilation Anesthesia and Endotracheal Tube Anesthesia in people with Kidney Transplantation and CKD (Chronic Kidney Disease) Stage 5D, run by Jianxing He.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Tubeless Spontaneous Ventilation Anesthesia and Endotracheal Tube Anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
12 Jan 2026to 31 Dec 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

About this study

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

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:

Read more
  • 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
Being tested
Tubeless Spontaneous Ventilation Anesthesia, Endotracheal Tube Anesthesia
Keywords
kidney transplantation, tubeless, ERAS, anesthesia
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tubeless Spontaneous Ventilation AnesthesiaProcedure or surgery

    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 or surgery

    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.
Study groups in NCT07377123
Study groupRoleWhat they receive
Tubeless Spontaneous Ventilation Anesthesia (TSVA)ExperimentalNot described
Receives: Procedure: Tubeless Spontaneous Ventilation Anesthesia
Endotracheal Tube Anesthesia (ETT)Active comparatorNot described
Receives: Procedure: Endotracheal Tube Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative Muscle Relaxant Usage

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

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

Secondary outcomes (12)

  1. Intraoperative Sedative and Analgesic Drug Usage

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

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

  2. Anesthetic Depth (BIS Monitoring)

    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.

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

  3. Intraoperative Ventilation Effect

    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

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

  4. Intraoperative Hemodynamic Stability

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

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

  5. Operation and Anesthesia Duration

    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.

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

  6. Postoperative Awakening and Recovery Time

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

    Measured: Perioperative/Periprocedural

  7. Perioperative Pain Scores

    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

    1. Pain when coughing
    2. No pain at rest, pain when taking deep breaths
    3. Mild pain at rest, tolerable
    4. Severe pain at rest, unbearable

    Measured: up to 24 hours post operatively

  8. Postoperative Pulmonary Complications

    Hypoxemia, Atelectasis, Pneumonia, Respiratory distress, etc.

    Measured: From intraoperative to three months postoperatively

  9. Non-Pulmonary Complications

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

    Measured: From intraoperative to three months postoperatively

  10. Serum creatinine

    Unit: μmol/L

    Measured: Postoperative day 1-90

  11. Estimated GFR

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

    Measured: Postoperative day 1-90

  12. Urine output

    24-hour total urine output

    Measured: up to 7 day post operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start12 Jan 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is designed as a single-center, prospective, randomized controlled clinical trial. Patients awaiting kidney transplantation at our hospital will be the study subjects and included in the study according to the inclusion/exclusion criteria. Using a block randomization method, two kidney transplant patients receiving kidneys from the same donor will be randomly assigned to the experimental group and the control group. Experimental Group: Tubeless spontaneous ventilation anesthesia (TSVA) Control Group: Endotracheal tube anesthesia (ETT) The two groups will be compared in terms of anesthetic drug dosage (dosage of muscle relaxants, anesthetic analgesics, and sedatives), anesthetic effect and intraoperative ventilation effect, intraoperative hemodynamics, surgery/anesthesia duration; postoperative awakening recovery time; perioperative patient pain scores; postoperative pulmonary complications and non-pulmonary complications, recovery of transplanted kidney function etc.
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07377123
Sponsor's protocol ID
ES-2025-130-02
Status last verified
Jan 2026
First submitted
4 Dec 2025
Last updated
29 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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