Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Normal saline group	Normal saline group	Continuously intravenous infusion of normal saline at a rate of 0.025 ml/kg/hour started immediately after enrollment until 08:00 AM on the postoperative day one.
Dexmedetomidine group	Dexmedetomidine	Continuously intravenous infusion of dexmedetomidine hydrochloride at a rate of 0.1 μg/ kg/hour (0.025 ml/kg/hour) started immediately after enrollment until 08:00 AM on the postoperative day one.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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%)

Locations (1): ICU, Beijing Tiantan Hospital, Capital Medical University
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Beijing, Beijing, China