Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

NCT07377123 | Not Yet Recruiting

• 1 other identifier: ES-2025-130-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

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

Keywords

kidney transplantation; tubeless; ERAS; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Intraoperative Sedative and Analgesic Drug Usage

  During surgery (intraoperative intervals, and end of anesthesia)

• Anesthetic Depth (BIS Monitoring)

  During surgery (intraoperative intervals, and end of anesthesia)

• Intraoperative Ventilation Effect

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

• Intraoperative Hemodynamic Stability

  During surgery (intraoperative intervals, and end of anesthesia)

• Operation and Anesthesia Duration

  During surgery (intraoperative intervals, and end of anesthesia)

Study Arms (2)

Tubeless Spontaneous Ventilation Anesthesia (TSVA)

EXPERIMENTAL

Procedure: Tubeless Spontaneous Ventilation Anesthesia

Endotracheal Tube Anesthesia (ETT)

ACTIVE COMPARATOR

Procedure: Endotracheal Tube Anesthesia

Interventions

Tubeless Spontaneous Ventilation Anesthesia PROCEDURE

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.

Tubeless Spontaneous Ventilation Anesthesia (TSVA)

Endotracheal Tube Anesthesia PROCEDURE

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.

Endotracheal Tube Anesthesia (ETT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Combined multi-organ transplantation.
• Previous history of organ transplantation other than kidney.
• Living donor kidney transplantation.
• 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.

Sponsors & Collaborators

• Jianxing He: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 29, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01