Pancreaticobiliary Diseases
Conditions
Interventions
Fospropofol Disodium Group:The propofol disodium group was given 5 µg of sufentanil, induced with 20 mg/kg of propofol disodium, and maintained sedation with 10–20 mg/kg/h of propofol disodium
Propofol Group:In the propofol group, 5 µg of sufentanil was administered, anesthesia was induced with 2 mg/kg of propofol, and sedation was maintained at 4-8 mg/kg/h
Sponsors
Luxian People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. No gender restrictions, aged 18–85 years, ASA classification II–III; 2. Patients who meet the diagnostic criteria and indications for ERCP surgery; 3. Complete data; 4. All meet the anesthesia and surgical indications; 5. No mental illness or cognitive impairment; 6. All patients were informed of the study content before enrollment and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals dependent on analgesic drugs; 2. Those with a history of chronic pain or neurological disorders; 3. Patients with heart, liver, or kidney dysfunction; 4. Allergy to anesthetic drugs; 5. Patients with active infections (such as pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, sequelae of cerebral infarction, etc.); 6. Patients who have participated in other clinical trials within the past week; 7. Any condition deemed by the investigator to be unstable or potentially jeopardizing the safety of the participant or their adherence to the study; 8. Pregnant or breastfeeding women; 9. Allergic reactions or previous serious adverse reactions to the study drug or its excipients; 10. Patients with mental disorders or social or geographic conditions that may interfere with adherence to the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anesthesia Success Rate for ERCP;Incidence of Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of induction sedation;Duration of anesthesia maintenance;Time to full alertness;Satisfaction of Surgeons with ERCP Procedures;Patient Satisfaction;Frequency of rescue sedative administration;Total dose of rescue sedative;Incidence of Cough Reflex;Incidence of Gag Reflex;Incidence of Body Movement;Incidence of Muscle Tremors;Incidence of Injection Pain;Incidence of Oxygen Desaturation;Severe oxygen desaturation (SpO2 < 90%);Incidence of Hypotension;Incidence of Severe Hypotension;Incidence of Bradycardia; | — |
Countries
China
Contacts
Public ContactYou Shuyong
Luxian People's Hospital
Outcome results
None listed