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

NCT07034963 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2025-07-24

No results posted yet for this study

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.

Conditions

  • Intrauterine Polyp
  • Intrauterine 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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Principal Investigators

  • Lijuan Yan · Department of Anesthesiology, The First Affiliated Hospital of Xiamen University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07034963 on ClinicalTrials.gov