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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

June 26, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Intrauterine PolypIntrauterine Synechiae
Interventions
DRUG

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.

DRUG

Intravenous the dose of esketamine ED95

The intervention group will be injected with the dose of esketamine ED95.

DRUG

Intravenous remifentanil 1μg∙kg-1

The control group will be injected with remifentanil 1μg∙kg-1.

Trial Locations (1)

361000

Department of Anesthesiology, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China, Xiamen

All Listed Sponsors
lead

The First Affiliated Hospital of Xiamen University

OTHER

NCT07034963 - Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care | Biotech Hunter | Biotech Hunter