Using dexmedetomidine to reduce postoperative delirium in brain tumor patients
Effect of Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors: a Randomized Placebo-controlled Trial
This study is testing if a medication called dexmedetomidine can help prevent confusion and delirium in patients having brain surgery for a tumor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 366 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06164314 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dexmedetomidine on reducing the incidence of postoperative delirium in patients undergoing elective craniotomy for temporal glioma. The study will involve strict adherence to protocols, with data collected and monitored securely in an electronic database. The primary hypothesis is that dexmedetomidine can mitigate neuroinflammation, enhance postoperative pain management, and improve sleep quality, thereby decreasing the likelihood of delirium after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with temporal glioma scheduled for elective craniotomy.
Not a fit: Patients with severe preoperative cognitive impairment or those with a history of traumatic brain injury or previous neurosurgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of postoperative delirium, improving recovery outcomes for patients with brain tumors.
How similar studies have performed: While the use of dexmedetomidine in this context is promising, further studies are needed to confirm its efficacy, as similar approaches have shown mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with temporal glioma scheduled for a elective craniotomy * Age ≥18 years * Obtain written informed consent. Exclusion Criteria: * Patients with severe preoperative cognitive impairment * History of traumatic brain injury or previous neurosurgery * History of psychotropic medications * Allergy to dexmedetomidine * Pregnant or lactating women * History of obstructive sleep apnoea syndrome * Severe bradycardia(heart rate \<40 beats/min), sick sinus syndrome or second-to-third degree atrioventricular block * Severe hepatic dysfunction * Severe renal dysfunction
Where this trial is running
Beijing
- Beijing Tiantan Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yuming Peng — Beijing Tiantan Hospital
- Study coordinator: Yuming Peng
- Email: florapym766@163.com
- Phone: 0086+18601076588
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.