Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial

Conditions
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Dexmedetomidine, Delirium, Awake Craniotomy

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: 0.9% saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DEX group<br>The DEX group patients will be received dexmedetomidine intraoperatively. | Drug: Dexmedetomidine<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>The placebo group patients will be received 0.9% saline intraoperatively. | Drug: 0.9% saline<br>* The 0.9% saline is administered with the same volume at the same speed as the other group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative delirium. | 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. | postoperative 5 day. |