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

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Central Nervous System Diseases

Treatments: Drug: Normal saline group; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04494828

KY2019-091-02A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Normal saline group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline group