NCT05168280 Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients
| NCT ID | NCT05168280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Dexmedetomidine |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2022-07-18 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2022-07-18 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Yuming Peng, MD,Ph.D
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT05168280 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dexmedetomidine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05168280 currently recruiting?
Yes, NCT05168280 is actively recruiting participants. Contact the research team at florapym766@163.com for enrollment information.
Where is the NCT05168280 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05168280 clinical trial?
NCT05168280 is sponsored by Beijing Tiantan Hospital. The principal investigator is Yuming Peng, MD,Ph.D at Beijing Tiantan Hospital. The trial plans to enroll 420 participants.