Painless gastroscopy sedation
Conditions
Interventions
Exploration of ED50 and ED95 doses of Oliceridine:The Dixon sequential method was used to determine the oliceridine dose for each patient.The initial oliceridine dose was set at 20 µg/kg, with a dose
if the patient had a negative insertion response, the dose for the next patient was decreased by 2 µg/kg. The trial proceeded sequentially until 9 reversal points (alternating positive and negative re
Sufentanil group: 0.1 µg/kg of sufentanil and 0.4 mg/kg of Cipepofol for induction before surgery.
Oliceridine group:22.93 µg/kg of Oliceridine and 0.4 mg/kg of Cipepofol for induction before surgery
Sponsors
The Second Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Select patients undergoing elective outpatient gastroscopy, regardless of gender, aged 18–64 years, stratified by age into two groups: 18–40 years and 41–64 years, with a 1:1 ratio in each age group; 2. BMI 18<=BMI<=28 kg/m^2; 3. ASA class I or II.
Exclusion criteria
Exclusion criteria: 1. Unwilling or unable to complete the entire study; 2. Acute upper respiratory tract infection; 3. Severe obstructive sleep apnea; 4. Uncontrolled severe hypertension; 5. Unstable angina or myocardial infarction; 6. Abnormal liver or renal function; 7. Moderate to severe anemia; 8. Acute upper gastrointestinal bleeding with shock; 9. Gastrointestinal obstruction with gastric retention; 10. Allergy to opioids, cyclopropofol, soy, or eggs; 11. Long-term use of sedative or analgesic drugs; 12. Psychiatric or neurological disorders; 13. Analgesics used for acute pain; 14. Chronic fatigue syndrome; 15. Hypokalemia; 16. Myasthenia gravis; 17. Psychiatric disorders; 18. Severe respiratory depression; 19. Acute or severe bronchial asthma occurring in an unmonitored setting or without resuscitation equipment; 20. Known or suspected gastrointestinal obstruction (including paralytic ileus); 21. Known hypersensitivity to this product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intraoperative respiratory depression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative Heart Rate Monitoring;Intraoperative mean arterial pressure monitoring;Intraoperative Spo2 monitoring;Anesthesia onset time;Procedure time;Awakening time;Recovery time;Ciprofol consumption and number of supplemental doses;Endoscopist satisfaction;Patient satisfaction;Postoperative PONV; Postoperative dizziness, fatigue,and abdominal pain;Intraoperative hypotension;Sinus bradycardia during surgery;Choking cough, body movement;Injection pain; | — |
Countries
China
Contacts
Public ContactXia Li
The Second Affiliated Hospital of Zhengzhou University
Outcome results
None listed