Digestive system diseases
Conditions
Interventions
The Remimazolam Group:Remimazolam sedation
The ciprofol group:Ciprofol sedation
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 60 and 75 years old, gender not restricted; 2. Patients planning to undergo painless gastroscopy and colonoscopy (gastroscopy combined with colonoscopy); 3. ASA score ranging from grade I to grade III; 4. BMI between 18 kg/m^2 and 28 kg/m^2; 5. The estimated operation time of gastroscopy and colonoscopy is no more than 30 minutes; 6. The patient fully understands and voluntarily participates in this study, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Complex endoscopic diagnosis and treatment procedures are required: such as endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, endoscopic mucosal resection, endoscopic submucosal dissection, oropharyngeal endoscopic myotomy, etc.; 2. Patients who are scheduled for tracheal intubation; 3. Patients who are determined to have difficult respiratory management (modified Mallory score level IV); 4. Patients with a previous history of anemia or thrombocytopenia, and whose test results still show abnormal indicators: hemoglobin (Hb) = 2.5×upper limit of normal (ULN), or total bilirubin (TBIL) >= 1.5×ULN, or serum creatinine (Scr) > ULN; 7. Patients who had a history of drug abuse and/or alcoholism within 2 years before the screening examination, and alcoholism is defined as an average daily alcohol consumption of more than 2 units (1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine); 8. Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs (sitting systolic blood pressure >= 160 mmHg during the screening period, and/or sitting diastolic blood pressure >= 100 mmHg during the screening period); 9. Sitting systolic blood pressure <= 90 mmHg during the screening period; 10. Patients allergic or contraindicated to benzodiazepines, opioids, propofol, etomidate, lidocaine and its components; 11. Patients who have participated in other drug clinical trials within the past 3 months; 12. Patients who refuse sedation, are unaccompanied, or have life-threatening comorbidities: such as severe arrhythmia, uncorrected heart failure, acute coronary syndrome, severe valve disease, high risk of reflux aspiration, severe airway obstruction, asthma attack, recent upper respiratory tract infection, severe OSAS patients; 13. The investigator deems that the patient is not suitable to participate in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of hypotension; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of sedation, success rate of first intubation, time to achieve adequate sedation, sedation awakening time, number of additional sedative doses;The incidence of hypotension requiring intervention treatment, as well as the changes in heart rate (HR) and SpO2; | — |
Countries
China
Contacts
Public ContactLei Qian
Sichuan Provincial People's Hospital
Outcome results
None listed