Awake Craniotomy, Delirium, Dexmedetomidine
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
DRUG0.9% saline
The 0.9% saline is administered with the same volume at the same speed as the other group.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYuming Peng, MD,Ph.D
Outcome results
None listed