Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors
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.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium. 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 Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors: a Randomized Placebo-controlled Trial
Overview
Neurosurgery is a risk factor for delirium. Dexmedetomidine might reduce delirium by reducing neuroinflammation, improving postoperative analgesia and sleep quality. The the primary hypothesis is that perioperative administration of dexmedetomidine can reduce the incidence of postoperative delirium
Detailed description
The investigators will be required to attend the professional training before recruitment and strictly adhere to the study protocol. All the raw data will be recorded in the case report forms. Data will be entered doubly performed by two investigators and monitored securely in an electronic database with password protection at the medical center. The data base will be locked after all data have been cleaned. All the original fles will be maintained in storage for 5 years after completion of the study.
Interventions
- Drug Dexmedetomidine
In Dex group, dexmedetomidine will continue to be used during and after surgery, with a infusion of 0.4ug/kg/ h from anesthesia induction to dural closure, and then 0.08ug/kg/ h to 48 hours postoperatively.In placebo group, equivalent normal saline will be injected during operation, and the intravenous analgesia pump will not contain dexmedetomidine after operation
Primary outcome measures
- the incidence of delirium postoperatively [Time frame: the postoperative 5 days]
Secondary outcome measures (4)
- the severity of postoperative delirium [Time frame: the postoperative 5 days]
- the intensity of pain [Time frame: the postoperative 5 days]
- the quality of sleep [Time frame: the postoperative 5 days]
- safety outcomes [Time frame: from the start of medicine infusion to 48 hours postoperatively]
Eligibility criteria
Inclusion criteria
- Patients with temporal glioma scheduled for a elective craniotomy
- Age ≥18 years
- Obtain written informed consent.
Exclusion criteria
- Patients with severe preoperative cognitive impairment
- History of traumatic brain injury or previous neurosurgery
- History of psychotropic medications
- Allergy to dexmedetomidine
- Pregnant or lactating women
- History of obstructive sleep apnoea syndrome
- Severe bradycardia(heart rate <40 beats/min), sick sinus syndrome or second-to-third degree atrioventricular block
- Severe hepatic dysfunction
- Severe 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 Tiantan Hospital — Beijing
Publications
- Zeng M, Zheng M, Wang J, Li S, Ji N, Peng Y. Effect of perioperative dexmedetomidine on postoperative delirium in patients with brain tumours: a protocol of a randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e084380. doi: 10.1136/bmjopen-2024-084380. PMID 39515867
Identifiers
NCT: NCT06164314 · 2023064