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Safety and Efficacy of Remimazolam Tosilate in Healthy Patients Undergoing Laparoscopic Appendectomy with General Anesthesia: a Randomized Controlled Trial.

Safety and Efficacy of Remimazolam Tosilate in Healthy Patients Undergoing Laparoscopic Appendectomy with General Anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034077
Enrollment
Unknown
Registered
2020-06-22
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Appendicitis

Interventions

Remimazolam Tosilate group:Anesthesia induction and maintenance with remimazolam tosilate
Propofol group:Anesthesia Induction and maintenance of propofol

Sponsors

Department of Anesthesiology, the Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Patients with complete medical history, including physical examination, vital signs, electrocardiogram and clinical laboratory examination; 2. Patients aged 18-45 years; 3. BMI is 18-30kg / m2, weight is 50-100kg; 4. ASA grades I-II; 5. Patients who voluntarily sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with any abnormal and clinically significant medical examination; 2. Evidence of any clinically relevant concomitant disease; 3. Patients with gastrointestinal, liver, kidney, respiratory system, cardiovascular, metabolic, immune and other diseases; 4. Patients with gastrointestinal surgery history; 5. Patients with myasthenia gravis; 6. Patients with central nervous system diseases (such as epilepsy), mental disorders or other mental nervous system diseases; 7. Patients with a history of postural hypotension, dizziness or vertigo; 8. Patients with chronic or acute infection; 9. Patients with history of allergy / hypersensitivity (including drugs or other substances); 10. Patients who took any medication at least one month before study administration; 11. Patients who participated in the trials of other study drugs within 2 months before or during the trial; 12. Smoker (10 cigarettes or 3 cigars or 3 pipes of cigarettes per day) or unable to prohibit smoking during the test; 13. Subjects of alcohol abuse (more than 60 g / day); 14. Target of drug abuse; 15. Blood donors (more than 100 ml blood donation within 4 weeks before study administration or during the trial); 16. Subjects with excessive physical activity (within 1 week before study administration or during study); 17. Subjects who are unwilling to use contraception or sexual partners are unwilling to use contraception during the trial; 18. People who are known to be allergic to benzodiazepines, flumazenil, anesthetics, or who have contraindications for the use of such drugs; any indication of long-term use of benzodiazepines (such as insomnia, anxiety, spasm) or positive urine drug screening in screening period; 19. Subjects with malampati score of 3 or 4; 20. Any other factors that are not suitable for the subjects to enter the trial in the opinion of the researcher.

Design outcomes

Primary

MeasureTime frame
Adverse reactions during injection;

Secondary

MeasureTime frame
BIS value;Hemodynamic index;Use of vasoactive drugs;Sufentanil dosage;Perioperative adverse events;Unplugging time;Awaking score (MOAA/S);Total amount and time of rimazolom infusion;intraoperative awareness;

Countries

China

Contacts

Public ContactYanwu Jin

The Second Hospital of Shandong University

xiaojin19781129@126.com+86 17660085535

Outcome results

None listed

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