Gastroscopy
Conditions
Interventions
Oselidine 1.5 mg group:The first patient was given 1.5 mg of oxilast, and the initial dose of propofol used for all patients was 1.5 mg/kg. The dose of propofol used for subsequent patients was determ
conversely, the dose of propofol for the next patient was increased by one dose. One dose gradient of propofol was defined as 0.2 mg/kg.
Oselidine 2.0 mg group:The first patient was given 2.0 mg of oxilast, and the initial dose of propofol used for all patients was 1.5 mg/kg. The dose of propofol used for subsequent patients was determ
Sponsors
Central Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 65–80 years, either gender; 2. ASA physical status I–II; 3. BMI 18–30 kg/m^2; 4. Passed preoperative anesthesia clinic evaluation, with voluntary informed consent signed by the patient or family member; 5. Gastroscope examination duration not exceeding 20 minutes.
Exclusion criteria
Exclusion criteria: 1. History of difficult ventilation or suspected difficult airway, or predicted difficult tracheal intubation (e.g., modified Mallampati score III–IV, congenital microstomia with macroglossia, mandibular hypoplasia, etc.); 2. Patients with a history of or current bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome, or upper respiratory tract infection within the past week, or those with obvious symptoms such as fever, wheezing, nasal congestion, or cough; 3. History of psychiatric disorders (e.g., schizophrenia, depression, etc.) or central nervous system diseases (e.g., epilepsy, Parkinson’s syndrome, Alzheimer’s disease, etc.); 4. Patients requiring complex endoscopic procedures (e.g., endoscopic ultrasound, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.), or those planned for tracheal intubation; 5. Continuous use of opioid analgesics for more than 10 days within the 3 months prior to randomization, or last opioid dose administered less than five half-lives before randomization; 6. Known hypersensitivity to opioids, propofol, or any other medications likely to be used during the trial (e.g., antiemetics, etc.); 7. Any other condition deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ED50 values of propofol for successful sedation in the two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time for achieving success through induction;The first time of adding propofol;The first increase in the dosage of propofol;The cumulative number of additional propofol administrations;Additional cumulative dose of propofol;Cumulative total dose of propofol;Recovery time;Vital signs (MAP, HR, SpO2, RR) at the following time points: before anesthesia induction (T0/baseline), immediately after oliceridine administration (T1), immediately after propofol administration (T2), just before gastroscopy insertion (T3), immediately after gastroscopy insertion (T4), 3 minutes after gastroscopy insertion (T5), 5 minutes after gastroscopy insertion (T6), and at the end of the procedure (T7).;Incidence of adverse reactions;Satisfaction score for endoscopic digestion examination;Anesthesiologist Satisfaction Score;Patient satisfaction score; | — |
Countries
China
Contacts
Public ContactCheng Hong
Department of Anesthesiology, Central Hospital Affiliated to Shandong First Medical University
Outcome results
None listed