Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJianxing He
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tubeless Spontaneous Ventilation Anesthesia
Procedure/Surgery1. 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 Anesthesia
Procedure/Surgery1. 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Tubeless Spontaneous Ventilation Anesthesia (TSVA)Experimental treatment 1 intervention
Group B: Endotracheal Tube Anesthesia (ETT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative Muscle Relaxant Usage
Total dosage of cisatracurium administered intraoperatively, including induction dose and supplemental doses.
Time frame
During surgery (intraoperative intervals, and end of anesthesia)Secondary outcomes
1
Intraoperative Sedative and Analgesic Drug Usage
Total amount of sedatives (e.g., propofol, dexmedetomidine) and analgesics (e.g., remifentanil, sufentanil).
Time frame
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.
Time frame
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
Time frame
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
Time frame
During surgery (intraoperative intervals, and end of anesthesia)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jianxing He
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
Source ClinicalTrials.gov
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