Dexmedetomidine's effects on brain function in elderly patients during anesthesia
Analyzing the Neuroprotective Effect of Dexmedetomidine in Terms of Preserving Brain Functional Connectivity in Elderly Patients After Major Surgery
NA · Pontificia Universidad Catolica de Chile · NCT04973124
This study is testing if the medication dexmedetomidine can help protect the brains of older patients during surgery and reduce the chances of memory problems afterwards.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile (other) |
| Locations | 1 site (Santiago, Metropolitana) |
| Trial ID | NCT04973124 on ClinicalTrials.gov |
What this trial studies
This study investigates the neuroprotective effects of dexmedetomidine in elderly patients undergoing surgery, focusing on its ability to preserve brain functional connectivity and reduce the risk of postoperative cognitive dysfunction (POCD) and postoperative delirium (POD). The trial involves administering dexmedetomidine or a placebo to eligible participants and assessing cognitive outcomes through neuroimaging and cognitive tests. The research aims to understand how dexmedetomidine may mitigate the inflammatory responses associated with surgery that can lead to cognitive decline in older adults.
Who should consider this trial
Good fit: Ideal candidates are elderly patients scheduled for surgery who are ASA I, II, or III and have a BMI under 35 kg/m2.
Not a fit: Patients with active delirium, mild cognitive impairment, or severe frailty may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of cognitive impairments in elderly patients after surgery.
How similar studies have performed: Previous studies have shown promising results with dexmedetomidine in reducing cognitive dysfunction, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I, II or III. * Body mass index (BMI) \<35 kg/m2. * Scheduled at least 6 days prior to surgery to allow adequate time for the baseline assessment. * Planned admission to the hospital for at least 2 days. Exclusion Criteria: * Active delirium diagnosed with the Confusion Assessment Method (CAM). * Mild cognitive impairment or dementia diagnosed with the Spanish-language version of the Montreal Cognitive Assessment MoCA-S1-2 score (score \<20 points). * In case the patient cannot answer the MoCA test, the instrument AD8-Ch will be applied. * Hospitalization within 3 months prior to enrollment to minimize risk of recent delirium history. * Severely frail condition defined with the Clinical Frailty Scale (CFS ≥7). * Inability to perform cognitive tests due to legal blindness or severe deafness * History of schizophrenia or psychosis. * Harmful alcohol use or alcohol dependence (AUDIT score ≥16 considering the standard drink equivalent determined by MINSAL). * History of benzodiazepines or marihuana consumption (more than 3 days per week). * Unable to pass assessment for capacity to provide informed consent. * Claustrophobia.
Where this trial is running
Santiago, Metropolitana
- Pontificia Universidad Catolica de Chile — Santiago, Metropolitana, Chile (RECRUITING)
Study contacts
- Principal investigator: Ignacio Cortinez, MD — Titular Profesor
- Study coordinator: Victor Contreras, MSN
- Email: vecontre@uc.cl
- Phone: 981895232
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.
Conditions: Anesthesia, Dexmedetomidine, Aging, Aged