Exploring Remimazolam Dosage for Different Age Groups in Anesthesia
The Investigation of the Dose Range of Remimazolam Besylate in Different Age Groups of Adults and Its Effects on Hemodynamics
This study is testing the right dose of remimazolam for older patients having non-heart surgeries to see if it helps them stay safe and feel better during anesthesia compared to propofol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1876 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06009991 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, parallel, controlled clinical study investigates the appropriate dose range of remimazolam besylate for patients of varying ages undergoing elective non-cardiac surgery under general anesthesia. The study aims to provide guidance for anesthesia induction and maintenance while assessing the incidence of perioperative hypotension and postoperative organ dysfunction compared to propofol. By focusing on patients over 45 years old, the research seeks to address the common issue of intraoperative hypotension and its associated risks. The findings could enhance the safety and efficacy of anesthesia practices in older patients.
Who should consider this trial
Good fit: Ideal candidates are patients over 45 years old undergoing elective non-cardiac surgery requiring general anesthesia.
Not a fit: Patients with significant cardiac issues, those undergoing emergency surgery, or those with a history of drug dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anesthesia practices and reduced postoperative complications for older patients.
How similar studies have performed: Previous studies have shown promising results with remimazolam in various anesthesia contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age above 45 years old; 2. American Society of Anesthesiologists grade Ⅰ-II; 3. patients undergoing tracheal intubation or laryngeal mask airway surgery under general anesthesia (intravenous anesthesia); 4. Informed consent: patients voluntarily participated in the trial and signed the informed consent form. Exclusion Criteria: 1. patients with cardiac function grade 3 or above; 2. difficult to observe the pupil size of head or neck surgery patients; 3. patients with multimodal anesthesia such as nerve block or spinal anesthesia compounded; 4. patients known to be allergic to remimazolam besylate or benzodiazepines; 5. major vascular surgery and the type of surgery that directly affects hemodynamics; 6. patients with coagulation dysfunction, endocrine diseases or other hemodynamic conditions; 7. minor surgery (operation duration \<1 hour); 8. surgery lasting more than 4 hours; 9. emergency surgery; 10. patients with a history of drug or alcohol dependence; 11. Subjects deemed unsuitable for the study by the investigator.
Where this trial is running
Wuhan, Hubei
- ongji Hospital, Tongji Medical College, Huazhong Science and Technology University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Ailin Luo — Tongji Hospital
- Study coordinator: Qiaoqiao Xu
- Email: qiaoqiaoxu@aliyun.com
- Phone: +8618771006963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.