Neoplasms

Nervous System Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Brain Neoplasms

Delirium

Central Nervous System Diseases

Emergence Delirium

Confusion

Neurobehavioral Manifestations

Neurologic Manifestations

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Postoperative Complications

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Dexmedetomidine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

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.

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 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.

Normal saline group

Jian-Xin Zhou, MD

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.

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.

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

Impact of Prophylactic Use of Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Pilot Randomized Controlled Trial

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.

Time from the end of operation to randomization

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%)

Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor	NCT04494828	Central Nervous...	Dexmedetomidine Normal saline g...	18 Years -	Capital Medical University
Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor	NCT04494828	Central Nervous...	Dexmedetomidine Normal saline g...	18 Years -	Capital Medical University

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