Clinical Trial

Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care

Active, Not Recruiting Phase 1/2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-20; most recent amendment 2025-07-21.
Status change: Recruiting → Active, Not Recruiting 2025-06-26
Trial Details
NCT Number NCT07034963
Lead Sponsor The First Affiliated Hospital of Xiamen University
Conditions Intrauterine Polyp, Intrauterine Synechiae
Enrollment 95 participants
Start Date 2025-06-26
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-24