Central Nervous System Diseases
Conditions
Keywords
delirium, postoperative, dexmedetomidine, intracranial operation, prevention
Brief summary
Postoperative delirium is one of the most common serious complications after major surgery and is associated with undesirable consequences. Prevention of postoperative delirium is recommended in the clinical guidelines and consensus statements. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has been investigated as a pharmacological intervention to prevent postoperative delirium. Several randomized controlled trials have shown that prophylactic use of low-dose dexmedetomidine may decrease the incidence of postoperative delirium in patients after cardiac and non-cardiac operations. However, neurosurgical patients are often excluded from previous studies due to potential consciousness and cognition impairment. The investigators design this pilot study aiming to clarify the feasibility and safety of use of low-dose dexmedetomidine for prevention of postoperative delirium in patients after intracranial operation for brain tumor.
Detailed description
Postoperative delirium is one of the most common serious complications after major surgery and is associated with undesirable consequences. Prevention of postoperative delirium is recommended in the clinical guidelines and consensus statements. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has been investigated as a pharmacological intervention to prevent postoperative delirium. Several randomized controlled trials have shown that prophylactic use of low-dose dexmedetomidine (0.1 ug/kg/hour without loading infusion) may decrease the incidence of postoperative delirium in patients after cardiac and non-cardiac operations. However, neurosurgical patients are often excluded from previous studies due to potential consciousness and cognition impairment. The investigators design this pilot randomized controlled trial aiming to clarify the feasibility and safety of use of low-dose dexmedetomidine for prevention of postoperative delirium in patients after intracranial operation for brain tumor.
Interventions
DRUGDexmedetomidine
Dexmedetomidine hydrochloride (200 μg/2 ml) is diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour (dexmedetomidine 0.1 μg/kg/hour). The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group. The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients after elective intracranial operation for brain tumor under general anesthesia and who are admitted to the ICU directly from the operating room or postoperative care unit.
Exclusion criteria
* age under 18 years; * admitted to the ICU after 22:00 PM; * medical records documented preoperative history of mental or cognitive disorders including schizophrenia, epilepsy, Parkinsonism, or dementia; * medical records documented inability to communicate in the preoperative period due to coma or language barrier; * history of drug abuse of psychoactive and anesthetic drugs; * known preoperative severe bradycardia (lower than 50 beats/min), sick sinus syndrome, second- or third-degree atrioventricular block, or left ventricular ejection fraction lower than 30%; * serious hepatic dysfunction defined as Child-Pugh class C; * severe renal dysfunction requiring renal replacement therapy before the surgery; * allergies to ingredients or components of dexmedetomidine hydrochloride; * American Society of Anesthesiologists classification of IV to VI; * moribund condition with low likelihood of survival for more than 24 hours; * pregnancy or lactation women; * current enrollment in another clinical trial; * refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of study agent interruption during the study | From the start of study agent infusion to postoperative day 1 | Predicted adverse events in the present study included bradycardia (defined as heart rate lower than 50 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), tachycardia (defined as heart rate greater than 100 beats/min), hypertension (defined as systolic blood pressure greater than 160 mmHg) and hypoxemia (defined as pulse oxygen saturation lower than 90%). The treatment of adverse events was determined by the responsible attending ICU physicians, who could stop the study agent infusion when the treatment failure or other conditions deemed necessary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from the end of operation to randomization | From the end of operation until the randomization, assessed up to 24 hours | Time from the end of operation to randomization |
| Duration of study agent infusion | From the start of study agent infusion to postoperative day 1 | Duration of study agent infusion |
| Incidence of adverse events from the start of study agent infusion until 24 hours or until ICU discharge | From the start of study agent infusion to postoperative day 1 | Include bradycardia (defined as heart rate lower than 55 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), and hypoxemia (defined as pulse oxygen saturation lower than 90%) |
| Non-delirium complications | From the start of study agent infusion to postoperative day 28 | Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection |
Countries
China
Outcome results
None listed