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Study on the application of Remazolam in the comfort medical treatment of gynecological surgery patients in plateau area

Study on the application of Remazolam in the comfort medical treatment of gynecological surgery patients in plateau area

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079926
Enrollment
Unknown
Registered
2024-01-16
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological operation

Interventions

Remazolam group:Anesthesia induction: remazolam 0.3 mg/kg+ Sufentanil 0.5 ug/kg + rocuronium 0.6 mg/kg. A modified vigilance/sedation score (MOAA/S) was used to evaluate the depth of sedation during a
Propofol group:Anesthesia induction: Propofol 2.0 mg/kg+ Sufentanil 0.5 ug/kg + rocuronium 0.6 mg/kg. A modified vigilance/sedation score (MOAA/S) was used to evaluate the depth of sedation during an

Sponsors

Zunyi Maternal And Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18= age =65 years old, female patients. (2) ASA grade I~II. (3) 18 kg/m2=BMI=28kg/m2. (4) General anesthesia patients undergoing gynecological endoscopic surgery. (5) The patient voluntarily participated in the study and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Allergic or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone and other drugs and their drug components. (2) Acute heart failure. Unstable angina pectoris; Myocardial infarction occurred within 6 months before screening. Resting ECG heart rate < 50 beats/min; Severe arrhythmia; Moderate to severe heart valve disease. (3) Patients with severe respiratory diseases. (4) Patients who did not receive formal antihypertensive therapy or poorly controlled blood pressure (SBP=160 mmHg or SBP=90 mmHg during the screening period). (5) Abnormal liver and kidney function. (6) Craniocerebral injury, possible intracranial hypertension, brain aneurysm, cerebrovascular accident history and central nervous system diseases. (7) Patients with mental system diseases and long-term history of taking psychiatric drugs and cognitive impairment. (8) Participants in any clinical trial as subjects within 3 months prior to enrollment. (9) Other conditions determined by the researcher to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Anterograde amnesia score;

Secondary

MeasureTime frame
Anxiety score;Depression score; 6/5000 MMSE score;

Countries

China

Contacts

Public ContactXue Zheng

Zunyi Maternal And Child Health Care Hospital

384618728@qq.com+86 151 8668 3595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026