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Clinical Trials in China / NCT05195034
Recruiting Not applicable

Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

NCT05195034 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Not applicable
Started
2022-03-31
Last updated
2025-02-13

Condition(s) studied

DexmedetomidineDeliriumAwake Craniotomy

Investigational drug(s) / intervention(s)

Dexmedetomidine →0.9% saline

Dexmedetomidine: The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with continuous infusion at a rate of 0.2 µg/kg/hour until the end of dural closure.

0.9% saline: The 0.9% saline is administered with the same volume at the same speed as the other group.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The incidence of postoperative delirium. — postoperative 5 day.
    postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tian Tan Hospital, Capital Medical University Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05195034 on ClinicalTrials.gov ↗ ← All trials in China