Using Dexmedetomidine to Reduce Delirium After Awake Brain Surgery
Official title: Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial
Run by Beijing Tiantan Hospital · NCT05195034 · Data updated 2026-11-12
This study is testing if a medication called dexmedetomidine can help prevent confusion after brain surgery in patients who are awake during the procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 31, 2022 |
| Main results expected | November 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 13, 2025 |
| Trial ID | NCT05195034 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are scheduled for selective awake craniotomies.
✕Probably not a fit
Patients with preoperative cognitive impairment, severe bradycardia, or significant hepatic or renal dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effect of dexmedetomidine on the incidence of postoperative delirium in patients undergoing awake craniotomies. Given that postoperative delirium is a common complication in this high-risk population, the study aims to determine if dexmedetomidine can effectively reduce its occurrence. Patients will receive either dexmedetomidine or a saline solution during their procedure, and their postoperative cognitive function will be monitored. The findings could provide insights into better management strategies for patients undergoing brain surgery.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative delirium in patients undergoing awake craniotomies, improving recovery outcomes.
How similar studies have gone: Previous studies have shown that dexmedetomidine may reduce delirium in non-cardiac surgery, but its specific effects on awake craniotomies remain largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing selective awake craniotomies. * Age ≥18 years. * Obtain written informed consent. Exclusion Criteria: * 1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA\< 18). * 2.Preoperative psychotropic medication within one year. * 3.BMI≤18 or ≥30 Kg/ m2 * 4.Pregnant or lactating women. * 5.History of traumatic brain injury or neurosurgery. * 6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block. * 7.Severe hepatic or renal dysfunction.
Where it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.