{"type":"trials","record":{"id":31627,"source_id":"clinicaltrials-gov","external_id":"NCT06090955","title":"Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly","brief_summary":"Postoperative delirium (POD) is the most common complications (\\~50-60%) in elderly and major challenges to our rapidly growing aging population. Growing evidence suggests a possible role for neuroinflammation in the development of delirium, which is facilitated by a transient increase in blood-brain barrier (BBB) permeability. Lidocaine and dexmedetomidine, commonly used anesthetic adjuncts, have anti-inflammatory properties. Both drugs are reported to have modulatory effect on the intergrity of BBB and associated with a beneficial effect on postoperative neurocognitive dysfunction. In this regard, The investigators aimed to prospectively compare the modulatory effect of the intraoperative administration of dexmedetomidine or lidocaine with a sham control group (normal saline solution) on surgery-induced BBB disruption.","overall_status":"Unknown","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Samsung Medical Center","enrollment":108,"countries":["South Korea"],"start_date":"2023-10-25","completion_date":"2024-12-31","last_update_date":"2024-04-17","source_url":"https://clinicaltrials.gov/study/NCT06090955","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:20:09.878+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years","comparator":"Control group","organization":"Samsung Medical Center","interventions":["Dexmedetomidine Injection [Precedex]","Lidocaine IV","normal saline"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Postoperative change of cerebrospinal-plasma albumin ratio (CPAR) — From the baseline to immediate postoperative values","The changes of inflammatory biomarker level in blood — From the baseline to immediate postoperative state and postopera…","The changes of neuronal damage biomarker level in blood — From the baseline to immediate postoperative state and postop…","The changes of inflammatory, neuronal damage, BBB permeability biomarker level in blood — From the baseline to immediat…","The incidence of postoperative delirium — From postoperative day 0 to 5","The subtype of postoperative delirium — From postoperative day 0 to 5","Delirium Rating Scale Revised (DRS-R-98) — From postoperative day 0 to 5","Onset and duration of delirium — From postoperative day 0 to 5","Pain score (NRS) — From postoperative day 0 to 5","Subjective sleep quality — From postoperative day 0 to 5","Montreal cognitive Assessment (MoCA) — at baseline and 7 days after surgery or at discharge","Ideal outcome of pancreatoduodenectmoy — postoperative day 30","non-delirium complications within 30 days after surgery — Within 30 days after surgery"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","source_has_results":false},"controlled_terms":["Delirium, Postoperative","Dexmedetomidine Injection [Precedex]","Lidocaine IV","normal saline"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: blood-brain barrier.","quality_checked_at":"2026-09-25T06:20:11.344357+00:00","duplicate_cluster_key":"id:nct06090955","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-10-25 to 2024-12-31","comparator":"Control group","confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:09.902Z","intervention":["Dexmedetomidine Injection [Precedex]","Lidocaine IV","normal saline"],"participants":108,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Postoperative change of cerebrospinal-plasma albumin ratio (CPAR) — From the baseline to immediate postoperative values","The changes of inflammatory biomarker level in blood — From the baseline to immediate postoperative state and postopera…","The changes of neuronal damage biomarker level in blood — From the baseline to immediate postoperative state and postop…","The changes of inflammatory, neuronal damage, BBB permeability biomarker level in blood — From the baseline to immediat…","The incidence of postoperative delirium — From postoperative day 0 to 5","The subtype of postoperative delirium — From postoperative day 0 to 5","Delirium Rating Scale Revised (DRS-R-98) — From postoperative day 0 to 5","Onset and duration of delirium — From postoperative day 0 to 5","Pain score (NRS) — From postoperative day 0 to 5","Subjective sleep quality — From postoperative day 0 to 5","Montreal cognitive Assessment (MoCA) — at baseline and 7 days after surgery or at discharge","Ideal outcome of pancreatoduodenectmoy — postoperative day 30","non-delirium complications within 30 days after surgery — Within 30 days after surgery"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"blood-brain-barrier-aging","is_published":true,"match_reasons":["Title contains controlled term: blood-brain barrier.","Abstract contains controlled term: blood-brain barrier.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Blood-brain barrier ageing","slug":"blood-brain-barrier-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/31627","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}