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Clinical study on the efficacy and safety of remazolam besylate for induction and maintenance of general anesthesia in gynecological laparoscopic surgery

Clinical study on the efficacy and safety of remazolam besylate for induction and maintenance of general anesthesia in gynecological laparoscopic surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068042
Enrollment
Unknown
Registered
2023-02-04
Start date
2023-02-04
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Gynecological uterine and adnexal diseases

Interventions

Experimental group:Remazolam sedation

Sponsors

Mindong Hospital Affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing gynecological laparoscopic general anesthesia surgery (except for patients with malignant tumors); 2. Age 18-60 years; 3 Body mass index (BMI): 18.5-30 kg/m^2; 4 American Society of Anesthesiologists Grading (ASA) Grades I-III; 5. Subjects voluntarily participate in the trial and sign the informed consent form of the trial.

Exclusion criteria

Exclusion criteria: 1. The subject expressly refuses to participate in this study; 2. Those who are allergic to opioids, benzodiazepines, propofol, flumazenil or naloxone drug excipients; 3. Use of ß receptor blockers, anxiolytics, and antidepressants; 4. Those suspected of abusing narcotic analgesics or sedatives and alcoholics; 5. ECG indicates heart rate 100 times/min or severe arrhythmia; 6. History of acute respiratory infection with no cure within 2 weeks; 7. Those with a history of severe cardio-brain, lung, liver, kidney or metabolic diseases, neuromuscular system diseases (such as myasthenia gravis) and mental diseases; 8. Patients with preoperative hypertension have a systolic blood pressure > 180 mmHg and (or) diastolic blood pressure > 110 mmHg or 90/60 mmHg for hypotensive patients ; 9. Those who have a history of abnormal surgical anesthesia recovery; 10. Predictors of the possibility or occurrence of difficult airways, such as modified Markovian grades III-IV; 11. Pregnant or lactating women and patients with a birth plan within 3 months; 12. Other subjects considered inappropriate by other investigators to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative hypotension;

Secondary

MeasureTime frame
Vital signs;Anesthesia wake time;Adverse reactions;

Countries

China

Contacts

Public ContactWeng Digui

Mindong Hospital Affiliated to Fujian Medical University

wdgmdyy813@163.com+86 137 0693 0791

Outcome results

None listed

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