Using dexmedetomidine to prevent delirium after brain surgery in older patients
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial
This study tests if giving dexmedetomidine during brain surgery can help older patients avoid confusion and delirium afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05168280 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of dexmedetomidine on preventing postoperative delirium in elderly patients undergoing craniotomy. It focuses on patients aged 65 and older, as they are at a higher risk for developing delirium after neurological procedures. The intervention involves administering dexmedetomidine compared to a saline solution during surgery. The goal is to determine if dexmedetomidine can effectively reduce the incidence of delirium in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older who are scheduled for selective craniotomy.
Not a fit: Patients with cognitive impairments, severe bradycardia, or those with a history of certain medical conditions or medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of postoperative delirium in elderly patients, improving their recovery and overall outcomes.
How similar studies have performed: Previous studies have shown that dexmedetomidine may reduce delirium in non-cardiac surgery patients, suggesting potential success in this novel application for elderly neurosurgery patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing selective craniotomy. * Age ≥65 years. * Obtain written informed consent. Exclusion Criteria: * Operation time less than 2 hours. * Refusal to provide written informed consent. * Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22). * Allergic to the study drug. * Body mass index ≤18 or ≥ 30 kg/m2. * History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs. * History of traumatic brain injury or neurosurgery. * Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block. * Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy). * The functional neurosurgery.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tian Tan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yuming Peng, MD,Ph.D — Beijing Tiantan Hospital
- Study coordinator: Yuming Peng, MD,Ph.D
- Email: florapym766@163.com
- Phone: 8610-59976658
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.