Using Dexmedetomidine to Reduce Delirium After Awake Brain Surgery
Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05195034 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for selective awake craniotomies.
Not a fit: Patients with preoperative cognitive impairment, severe bradycardia, or significant hepatic or renal dysfunction may not benefit from this study.
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 performed: Previous studies have shown that dexmedetomidine may reduce delirium in non-cardiac surgery, but its specific effects on awake craniotomies remain largely untested.
Eligibility criteria
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 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.