Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Dexmedetomidine, Delirium, Awake Craniotomy

In brief

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.

Key facts

Study ID

NCT05195034

Run by

Beijing Tiantan Hospital

People needed

210

Starts

2022-03-31

Expected to finish

2025-12-31

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing selective awake craniotomies.
• Age ≥18 years.
• Obtain written informed consent.

You may not qualify if…

• 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.

Where it is running

• Beijing Tian Tan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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