None
Conditions
Interventions
P group:Oliceridine was administered as an intravenous bolus (starting dose 20 µg/kg, step size 5 µg/kg), followed immediately by a 5-mL flush of 0.9% sodium chloride solution. Two minutes later, the
R group:Oliceridine was administered as an intravenous bolus (starting dose 20 µg/kg, step size 5 µg/kg), followed immediately by a 5-mL flush of 0.9% sodium chloride solution. Two minutes later, the
Sponsors
The First Hospital of Jiaxing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18–65 years; (2) Scheduled for elective outpatient painless gastroscopy; (3) American Society of Anesthesiologists (ASA) physical status I–II; (4) 18.5 kg/m^2<=BMI<30.0 kg/m^2.
Exclusion criteria
Exclusion criteria: (1) known hypersensitivity or allergy to any study medication; (2) pregnancy or lactation; (3) long-term use of sedative, analgesic, or antiepileptic medications, or a history of opioid abuse; (4) clinically judged unstable cardiopulmonary disease or conditions deemed unsuitable for outpatient sedation; (5) acute respiratory tract infection within the preceding 2 weeks or acute exacerbation of chronic respiratory disease; (6) poorly controlled blood pressure at screening (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg on repeated measurement); (7) a history of severe hepatic dysfunction (e.g., Child–Pugh class C) or end-stage renal disease requiring maintenance dialysis; (8) anticipated difficult airway (e.g., modified Mallampati class IV or other features suggesting difficult mask ventilation or tracheal intubation); (9) increased risk of aspiration (e.g., inadequate fasting, persistent nausea or vomiting, or clinically significant gastroesophageal reflux); (10) inability to cooperate with sedation assessment; or (11) any other condition judged by the investigators to make participation inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median effective dose, ED50;Therapeutic index (ED95/ED50) ;95% effective dose, ED95; | — |
Countries
China
Contacts
Public ContactLi Hu
The First Hospital of Jiaxing
Outcome results
None listed