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

• Status: Completed
• Trial end date: 2020-12-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University
• Treatments: Dexmedetomidine

Criteria

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.