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Completed
NCT05168280
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients
Conditions: Dexmedetomidine, Postoperative Delirium
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 420
Sponsor: Beijing Tiantan Hospital
Location: Beijing Tian Tan Hospital, Capital Medical University Beijing Beijing Municipality
Summary
Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.
Eligibility Criteria
Inclusion Criteria:
* Patients undergoing selective craniotomy.
* Age ≥65 years.
* Obtain written informed consent.
Exclusion Criteria:
* Operation time less than 2 hours.
* Refusal to provide written informed consent.
* Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
* Allergic to the study drug.
* Body mass index ≤18 or ≥ 30 kg/m2.
* History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
* History of traumatic brain injury or neurosurgery.
* Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
* Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
* The functional neurosurgery.
Source: ClinicalTrials.gov (NCT05168280). StuddyBuddy aggregates publicly available trial information.