Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: Kidney Transplantation; CKD (Chronic Kidney Disease) Stage 5D
• Intervention / Treatment: Procedure: Tubeless Spontaneous Ventilation Anesthesia; Procedure: Endotracheal Tube Anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tubeless Spontaneous Ventilation Anesthesia (TSVA)	Procedure: Tubeless Spontaneous Ventilation Anesthesia; 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.
Active Comparator: Endotracheal Tube Anesthesia (ETT)	Procedure: Endotracheal Tube Anesthesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Muscle Relaxant Usage	Total dosage of cisatracurium administered intraoperatively, including induction dose and supplemental doses.	During surgery (intraoperative intervals, and end of anesthesia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Sedative and Analgesic Drug Usage	Total amount of sedatives (e.g., propofol, dexmedetomidine) and analgesics (e.g., remifentanil, sufentanil).	During surgery (intraoperative intervals, and end of anesthesia)
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.	During surgery (intraoperative intervals, and end of anesthesia)
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	Intraoperative key time points (e.g., post-induction, during operation, end of operation)
Intraoperative Hemodynamic Stability	Invasive arterial pressure variability/Blood pressure fluctuations at key time points	During surgery (intraoperative intervals, and end of anesthesia)
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.	During surgery (intraoperative intervals, and end of anesthesia)
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	Perioperative/Periprocedural
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; Pain when coughing; No pain at rest, pain when taking deep breaths; Mild pain at rest, tolerable; Severe pain at rest, unbearable	up to 24 hours post operatively
Postoperative Pulmonary Complications	Hypoxemia, Atelectasis, Pneumonia, Respiratory distress, etc.	From intraoperative to three months postoperatively
Non-Pulmonary Complications	Hoarseness, Vocal cord paralysis, Nausea/vomiting, Arrhythmia, Delirium, etc.	From intraoperative to three months postoperatively
Serum creatinine	Unit: μmol/L	Postoperative day 1-90
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	Postoperative day 1-90
Urine output	24-hour total urine output	up to 7 day post operatively

Collaborators and Investigators

• Sponsor: Jianxing He

Study record dates

Study Major Dates

• Study Start (Estimated): January 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: anesthesia; kidney transplantation; ERAS; tubeless
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: ES-2025-130-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No