Clinical trial NCT04494828: Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor
Official title: Impact of Prophylactic Use of Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Nervous System Diseases
Keywords: delirium
postoperative
dexmedetomidine
intracranial operation
prevention
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of study agent interruption during the study
timeFrame: From the start of study agent infusion to postoperative day 1
Secondary outcomes:
measure: Time from the end of operation to randomization
timeFrame: From the end of operation until the randomization, assessed up to 24 hours
measure: Duration of study agent infusion
timeFrame: From the start of study agent infusion to postoperative day 1
measure: Incidence of adverse events from the start of study agent infusion until 24 hours or until ICU discharge
timeFrame: From the start of study agent infusion to postoperative day 1
measure: Non-delirium complications
timeFrame: From the start of study agent infusion to postoperative day 28
Other outcomes:
Locations:
city: Beijing
country: China
facility: ICU, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Jian-Xin Zhou, MD
role: STUDY_CHAIR
References:
citation: He X, Cheng KM, Duan YQ, Xu SS, Gao HR, Miao MY, Li HL, Chen K, Yang YL, Zhang L, Gu HQ, Zhou JX. Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial. BMC Neurol. 2021 Dec 4;21(1):472. doi: 10.1186/s12883-021-02506-z.