Complex endoscopic therapy
Conditions
Interventions
Control group:Propofol TCI sedation is guided by the MOAA/S score, with the target sedation level set at a MOAA/S score of 2. If the score exceeds 2, the target concentration of propofol in the TCI sy
if the score is below 2, the target concentration of propofol in the TCI system should be decreased.
Trial group:Propofol TCI sedation is guided by the PSi index, with the target sedation level set at a PSi value of 35–50. When the PSi value falls below 35, the target concentration of propofol in the
when the PSi value exceeds 50, the target concentration of propofol in the TCI system should be increased.
Sponsors
General Hospital of the Northern Theater of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients scheduled for elective painless complex endoscopic procedures, such as ERCP or ESD, refer to minimally invasive interventional techniques performed via endoscopy for deep-seated lesions of the gastrointestinal tract, involving complex anatomical manipulation and requiring high technical precision; these procedures carry a higher risk of complications—including bleeding, perforation, and infection—compared to conventional endoscopic procedures; 2. ASA physical status classification I–III; 3. Body mass index (BMI) of 18–30 kg/m²; 4. Anesthesia method: intravenous anesthesia; 5. Willingness to provide informed consent and strictly adhere to the clinical study protocol.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1 People with circulatory system diseases (heart failure, angina, myocardial infarction, arrhythmia); 2. Uncontrolled hypertension (systolic blood pressure>=160 mmHg or diastolic blood pressure >=100 mmHg) or hypotension (systolic blood pressure 2h) expected operation time; 6. Liver insufficiency: Child-Pugh rating C or above; 7. Renal insufficiency: glomerular filtration rate 2.5 mg/dL; 8. Anemia or thrombocytopenia (hemoglobin < 90 g/L, platelet count < 80 × 10^9 /L); 9. Those who have negative modified Allen test; 10. People with allergic to experimental drugs; 11. People who have been drinking for a long time or use psychotropic drugs and painkillers; 12. Those with previous history of anesthesia and sedation accidents and contraindications to anesthesia and sedation; 13. Those who have participated in clinical trials of other drugs in the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of sedation-related adverse events [including: 1. Hypoxemia (SpO2 120 bea; | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean arterial pressure (MAP), heart rate (HR), and blood oxygen saturation (SPO2) were observed and recorded at the time of entering the room (T0), 2min after administration (T1), at the time of endoscope insertion (T2), at the end of operation (T3), and at the time of awakening (T4).;Satisfaction score of patients and endoscopists;Endoscopic procedure time (time from entry of the endoscope into the oral cavity to exit the oral cavity);Time to recovery of sedation (time from exit of the endoscope into the mouth to patient's recovery to Aldrete score =10);Adverse events related to endoscopic procedures (e.g., unexpected bleeding, perforation); | — |
Countries
China
Contacts
Public ContactDiao Yugang
General Hospital of the Northern Theater of the Chinese People's Liberation Army
Outcome results
None listed