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Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation
Sponsor: Jianxing He
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
Official title: Application of Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation Surgery: A Single-Center, Prospective, Randomized Controlled Trails
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-01-12
Completion Date
2027-12-31
Last Updated
2026-01-29
Healthy Volunteers
No
Interventions
Tubeless Spontaneous Ventilation Anesthesia
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 Anesthesia
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.