Comparing Remimazolam and Propofol for Delirium in Neurosurgery Patients
Effect of Remimazolam Versus Propofol Anesthesia on Postoperative Delirium in Neurosurgical Patients: A Randomised, Controlled, Noninferiority Trial
This study is testing if using remimazolam instead of propofol during neurosurgery can help reduce the chances of patients experiencing delirium after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 696 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06115031 on ClinicalTrials.gov |
What this trial studies
This study evaluates the incidence of postoperative delirium in neurosurgical patients receiving either remimazolam-based or propofol-based total intravenous anesthesia (TIVA). Remimazolam is a newly approved short-acting benzodiazepine that may offer a safer alternative to propofol, which has been associated with higher rates of postoperative complications. The trial is designed as a prospective, randomized, double-blinded, active comparator-controlled, non-inferiority trial to assess the effectiveness and safety of remimazolam compared to propofol. The study aims to provide insights into the potential benefits of remimazolam in reducing postoperative delirium.
Who should consider this trial
Good fit: Ideal candidates for this study are patients classified as ASA class I to III who are undergoing neurosurgery.
Not a fit: Patients with severe respiratory, cardiovascular, or hepatic disease, or those with preoperative delirium, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia protocols that reduce the incidence of postoperative delirium in neurosurgical patients.
How similar studies have performed: While there is limited research specifically comparing remimazolam to propofol regarding postoperative delirium, the safety profile of remimazolam suggests potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American society of anesthesia (ASA) class I - III Exclusion Criteria: * Severe respiratory, cardiovascular, or hepatic disease (child-pugh C) * Dependency on psychiatric drugs or alcohol * Severe sensory impairments that impede communication * Preoprative delirium * Hypersensitivity, allergies, or contraindication to the study drugs.
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Jiseon jeong — Samsung Medical Center
- Study coordinator: jeayoun kim
- Email: kimjy0705@naver.com
- Phone: +821039268786
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.