Painless gastrointestinal endoscopy
Conditions
Interventions
Group fospropofol:Inject the corresponding dose of fospropofol disodium
Sponsors
Chengdu Seventh People's Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Age >=65 years; 2.ASA physical status I–III; 3.Scheduled for painless gastrointestinal endoscopy;
Exclusion criteria
Exclusion criteria: 1.Patients with known allergy to fospropofol disodium or remimazolam; 2.Body mass index (BMI) >30 kg/m^² or <18 kg/m^²; 3.Presence of severe central nervous system disorders (e.g., stroke, epilepsy, Parkinson's disease) or psychiatric disorders (e.g., schizophrenia, major depressive disorder); 4.Severe respiratory insufficiency, severe obstructive pulmonary disease, hypoxemia (preoperative SpO2 <95% without oxygen supplementation), or presence of a difficult airway; 5.History of substance abuse or long-term use of anesthetics, sedatives, or analgesics; 6.Recent use of medications that affect drug metabolism; 7.Congestive heart failure classified as New York Heart Association (NYHA) class III or IV; 8.Untreated or unstable ischemic heart disease; 9.History of severe aortic or mitral valve disease, including severe regurgitation or severe stenosis; 10.Severe hepatic or renal dysfunction (ALT, AST, blood urea nitrogen, or creatinine levels exceeding twice the upper limit of normal); 11.Preoperative systolic blood pressure <90 mmHg or bradycardia (heart rate <50 beats/min); 12.Presence of severe coagulation abnormalities, severe endocrine disorders, or other conditions that affect hemodynamic status; 13.Patients already enrolled in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ED95 and ED99 of fospropofol disodium; | — |
Secondary
| Measure | Time frame |
|---|---|
| frequency and dose of vasoactive drug administration;duration of gastrointestinal endoscopy;Occurrence of hypoxemia, hypertension, hypotension, tachycardia, bradycardia, cerebral oxygen desaturation, nausea and vomiting, injection pain, pruritus, and paresthesia;Vital signs;duration of anesthesia; | — |
Countries
China
Contacts
Public ContactHui Zhong
Chengdu Seventh People's Hospital
Outcome results
None listed