Gastrointestinal diseases
Conditions
Interventions
Ciprofol Group:For anesthesia induction, remimazolam tosilate injection was initially administered at 0.3 mg/kg. After the initial loading dose was given over 1 minute, additional doses of 2.5 mg were
Ciprofol Group:For anesthesia induction, ciprofol was administered by slow intravenous injection in divided doses at 0.2–0.4 mg/kg (0.1–0.2 mg/kg every 30–60 seconds), followed by intermittent supplem
Sponsors
The Second People's Hospital of Chengdu, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–85 years (inclusive), regardless of sex, scheduled to undergo non-intubated general anesthesia for gastroscopy, colonoscopy, or combined procedures; 2. Body weight >45 kg for females and >50 kg for males, with a body mass index (BMI) of 18–30 kg/m² (inclusive); 3. American Society of Anesthesiologists (ASA) physical status I–III; 4. Peripheral oxygen saturation (SpO2) =90% while breathing room air; 5. Assessed by the Department of Anesthesiology as suitable for non-intubated general anesthesia or deep sedation management; 6. Able to understand the purpose and procedures of the study, voluntarily sign written informed consent, and agree to wear wearable vital sign monitoring devices during the examination.
Exclusion criteria
Exclusion criteria: 1. Known history of allergy or hypersensitivity to benzodiazepines, remimazolam tosilate, (cyclo)propofol, or any of their excipients; 2. Pregnant or breastfeeding women; 3. Patients with severe respiratory diseases (e.g., obstructive sleep apnea syndrome, acute respiratory tract infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc.); 4. History of myocardial infarction or unstable angina within 6 months prior to screening; or findings at screening indicating bradycardia (heart rate =50 bpm); or presence of third-degree atrioventricular block, severe arrhythmia, or severe valvular heart disease; 5. Severe hepatic impairment (Child–Pugh class C), or severe and unstable renal dysfunction; 6. Pre-assessed as having a definite or highly suspected difficult airway (e.g., Mallampati class IV, severe cervical spine limitation, significantly restricted mouth opening), deemed unsuitable for safely completing gastrointestinal endoscopy under non-intubated conditions; 7. Participation in another interventional clinical trial within 30 days prior to enrollment that may interfere with the results of this study; 8. Other conditions that, in the investigator’s judgment, may affect safety or interfere with the evaluation of primary endpoints, such as inability to cooperate with monitoring, inability to reliably wear wearable devices, or abnormal mental status.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum decrease in mean arterial pressure (MAP) from baseline during the procedure (mmHg); | — |
Secondary
| Measure | Time frame |
|---|---|
| Trajectories of vital signs;Adverse events and interventions;Sedation efficacy ; | — |
Countries
China
Contacts
Public ContactZheng Zhuo
The Second People's Hospital of Chengdu, Sichuan University
Outcome results
None listed