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Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care
Sponsor: The First Affiliated Hospital of Xiamen University
Summary
Cervical dilation-induced somatic responses remain a critical challenge in ambulatory hysteroscopic surgery. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, exhibits unique analgesic and sedative properties that may enhance perioperative somatic response inhibition. However, the effective dose of esketamine under dexmedetomidine-remifentanil based monitored anesthesia care (MAC) during ambulatory hysteroscopic surgery remains to be determined. This prospective dose-finding study aimed to establish the median effective dose (ED50) and 95% effective dose (ED95) of esketamine for cervical response suppression. Afterwards, the investigators will conduct an RCT study to evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.
Key Details
Gender
FEMALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2025-06-26
Completion Date
2028-06-30
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
Determine the ED50 and ED95 of esketamine
According to Dixon's up-and-down sequential design, esketamine will be initiated at 0.3 mg∙kg-1 intravenously, followed by dose adjustments (0.02 mg∙kg-1 increments/decrements) based on somatic responses to cervical dilation (positive: any movement; negative: no movement). The tests will continued until six crossover pairs are achieved.
Intravenous the dose of esketamine ED95
The intervention group will be injected with the dose of esketamine ED95.
Intravenous remifentanil 1μg∙kg-1
The control group will be injected with remifentanil 1μg∙kg-1.
Locations (1)
Department of Anesthesiology, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China
Xiamen, Fujian, China