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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tubeless Spontaneous Ventilation Anesthesia (TSVA) | Experimental |
| |
| Endotracheal Tube Anesthesia (ETT) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tubeless Spontaneous Ventilation Anesthesia | Procedure |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
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|
| Endotracheal Tube Anesthesia | Procedure |
|
|
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
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |