NCT05195034 Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies
| NCT ID | NCT05195034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Dexmedetomidine |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2022-03-31 |
| 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 210 participants in total. It began in 2022-03-31 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 complication, and the incidence of POD ranges from 10% to 60%. Previous studies suggested that frontal approach and tumor located at the temporal lobe were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing awake craniotomies are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine (DEX) on POD for patients undergoing awake craniotomies remains unclear. The purpose of this study was to investigate the effect of DEX on POD in patients undergoing awake craniotomies.
Eligibility 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.
Contact & Investigator
Yuming Peng, MD,Ph.D
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT05195034 clinical trial?
This trial is open to participants of all sexes, aged 18 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 NCT05195034 currently recruiting?
Yes, NCT05195034 is actively recruiting participants. Contact the research team at florapym766@163.com for enrollment information.
Where is the NCT05195034 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05195034 clinical trial?
NCT05195034 is sponsored by Beijing Tiantan Hospital. The principal investigator is Yuming Peng, MD,Ph.D at Beijing Tiantan Hospital. The trial plans to enroll 210 participants.