NCT06990763

Brief Summary

To explore the related mechanisms by which remimazolam regulates hemodynamic stability, inflammatory factors and the immune system in patients undergoing general anesthesia for gynecological surgeries.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

April 20, 2025

Last Update Submit

May 17, 2025

Conditions

Gynecological Disease

Keywords

remimazolampropofolgynecological disease

Outcome Measures

Primary Outcomes (1)

  • Levels of serum N/OFQ, IL-6, STAT3

    perioperatively/periprocedurally

Secondary Outcomes (2)

  • Heart rate

    during the surgery

  • mean arterial pressure

    during the surgery

Study Arms (2)

Remimazolam group

EXPERIMENTAL

Remimazolam was used for anesthesia induction and maintenance

Drug: Remimazolam

Propofol group

ACTIVE COMPARATOR

Anesthesia induction and maintenance were carried out using propofol

Drug: propofol

Interventions

RemimazolamDRUG

Remimazolam, sufentanil and rocuronium were used during induction, and remimazolam and refentanil were used during maintenance

Remimazolam group
propofolDRUG

Propofol, sufentanil and rocuronium were used during induction, and propofol and remifentanil were used during maintenance

Propofol group

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patient or their family members sign the informed consent form
  • Age: 18-64 years old, BMI: 18-30kg/m2
  • ASA Grade Ⅰ or Ⅱ
  • Patients undergoing gynecological surgeries (laparoscopic total hysterectomy, adnexectomy and myomectomy)

You may not qualify if:

  • People who are allergic to remimazolam or benzodiazepinesThyroid disease
  • Long-term use of benzodiazepines
  • Pregnancy or lactation
  • Have a history of drug abuse or alcoholism
  • Patients with contraindications for surgery
  • Patients with hypertension (clinically diagnosed with hypertension) and patients with coronary heart disease (with typical angina pectoris symptoms and excluding aortic valve lesions, with a clear history of old myocardial infarction, with a clear history of acute myocardial infarction, and CAG finding coronary artery stenosis greater than or equal to 70%)
  • Patients with arrhythmia, heart failure, renal failure, and those who have recently taken cardiovascular active drugs
  • Endocrine disorders such as hyperthyroidism and pheochromocytoma that may affect the hemodynamic level of the body
  • Patients with ketoacidosis and lactic acidosis
  • Abnormal liver function, ALT\> three times the upper limit of the normal value;
  • Renal failure (serum creatinine \>3mg/dl or creatinine clearance rate \<30ml/min)
  • Patients who have been using sedatives or antidepressants for a long time, or have a history of alcohol abuse or drug dependence
  • Asthma or reactive airway diseases
  • Combined with underlying cognitive function abnormalities
  • Those who experienced adverse events such as shock, severe hypotension and severe arrhythmia during the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

remimazolamPropofol

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • yi Han

    Second Hospital of Shanxi Medical University

    STUDY DIRECTOR

Central Study Contacts

ran Zhang

CONTACT

1783515835217835158352@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 20, 2025

First Posted

May 25, 2025

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share