Frailty
Conditions
Interventions
Non-frail Group:Intravenous anesthesia with ciprofol combined with esketamine (BCD-UDM sequential dose-escalation trial)
Frail Group:Intravenous anesthesia with ciprofol combined with esketamine (BCD-UDM sequential dose-escalation trial)
Sponsors
Wuhan Fourth Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years old, gender not restricted; 2. Scheduled for diagnostic or therapeutic upper gastrointestinal endoscopy (gastroscopy); 3. American Society of Anesthesiologists (ASA) classification I-III; 4. Body Mass Index (BMI) ranging from 18.0 kg/m^2 to 28.0 kg/m^2; 5. The patient or their legal representative understands the research content and voluntarily signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known history of allergy to ciprofol, esketamine, propofol, soybeans, eggs, or any excipients in the prescription; 2.Presence of severe cardiovascular diseases: uncontrolled hypertension (resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg), unstable angina, myocardial infarction within the past 6 months, severe arrhythmias (such as third-degree atrioventricular block, sick sinus syndrome), New York Heart Association (NYHA) functional class III-IV; 3.Presence of severe respiratory diseases: severe chronic obstructive pulmonary disease (GOLD Group E, high risk of acute exacerbation), acute exacerbation of bronchial asthma, untreated severe obstructive sleep apnea syndrome (AHI > 30 events/hour); 4.Presence of severe hepatic insufficiency (Child-Pugh Class C) or renal insufficiency (requiring renal replacement therapy); 5.History of psychiatric disorders (such as schizophrenia), epilepsy, increased intracranial pressure, or recent history of cerebrovascular accident; 6.Uncontrolled glaucoma or increased intraocular pressure; 7.Known or suspected history of drug abuse or alcohol dependence; 8.Other conditions deemed by the investigator as unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 90% effective dose (ED90) of ciprofol; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hypopiesia;From the end of the examination to the time when the Aldrete score reaches or exceeds 9 points;Bradycardia;Respiratory depression;Proportion of patients requiring Ciprofol-induced sedation rescue;Nausea and vomiting;Duration of gastroscopy; | — |
Countries
China
Contacts
Public ContactHui Yu
Wuhan Fourth Hospital
Outcome results
None listed