Abstract
OBJECTIVE: To investigate the median effective dose (ED(50)) and 95% effective dose (ED(95)) of oliceridine combined with propofol for painless gastroscopy in adults. METHODS: Patients underwent painless gastroscopy were divided to male and female cohorts. A modified Dixon's up-and-down sequential method was employed, with an initial oliceridine dose of 20 μg·kg(-1) for both cohorts. Subsequent dosing adjustments were determined by the procedural success or failure of the preceding patient. The oliceridine dose was increased or decreased by a ratio of 1:1.2 for positive responses or negative responses. We recorded the time of successful induction, examination time, vital signs (HR, SpO(2) and MAP) at predefined phases (including baseline T(0), post-induction time T(1), completion time T(2), and departure time T(3)), induction dose and total dose of propofol, dose of oliceridine, intraoperative adverse events (including hypoxemia, respiratory depression, hypotension, and bradycardia), postoperative adverse events (including nausea, vomiting, and dizziness), and vasoactive agent administration during the procedure. Probit analysis was subsequently performed to determine the ED(50), ED(95) and corresponding 95% confidence intervals (CIs) of oliceridine in painless gastroscopy combined with propofol. RESULTS: The ED(50) and ED(95) of oliceridine combined with propofol were determined as 12.63 μg·kg(-1) (95% CI: 11.43-13.79) and 14.46 μg·kg(-1) (95% CI: 13.41-20.33) in males, and 10.38 μg·kg(-1) (95% CI: 9.02-11.96) and 13.19 μg·kg(-1) (95% CI: 11.62-28.23) in females. Male negative subgroup required higher oliceridine doses (P < 0.05), while female negative subgroup had lower total propofol dose yet higher oliceridine doses (P < 0.05). Females in the negative subgroup used more propofol (P < 0.05), and both sexes' negative subgroups consumed more oliceridine (P < 0.05). In males, SpO(2) rose at T(1) and T(2) (P < 0.01), and MAP dropped at T(2) and T(3) (P < 0.05). In females, HR decreased at T(2) (P < 0.05), SpO(2) increased at T(1) (P < 0.05), and MAP fell at T(2) and T(3) (P < 0.05). Adverse events included postoperative dizziness (12.50%), nausea (4.17%), and fatigue (4.17%) in females, and vomiting (5.56%) in males. CONCLUSION: The use of oliceridine (13.19-14.46 μg·kg(-1)) and propofol was associated with safety, efficacy, and lower complication rates during painless gastroscopy. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=249883, identifier ChiCTR2400093609.