Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, 0.9% saline.
- Who it may be relevant to
- Registry conditions: Dexmedetomidine, Delirium, Awake Craniotomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial
Overview
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
- Drug 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. - Drug 0.9% saline
The 0.9% saline is administered with the same volume at the same speed as the other group.
Primary outcome measures
- The incidence of postoperative delirium. [Time frame: postoperative 5 day.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Beijing Tian Tan Hospital, Capital Medical University — Beijing
Publications
- Li M, Liu M, Cui Q, Zeng M, Li S, Zhang L, Peng Y. Effect of dexmedetomidine on postoperative delirium in patients undergoing awake craniotomies: study protocol of a randomized controlled trial. Trials. 2023 Sep 25;24(1):607. doi: 10.1186/s13063-023-07632-2. PMID 37743486
Identifiers
NCT: NCT05195034 · 2022-01-04