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

NCT ID: NCT04494828

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2020-12-21

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.

Conditions

Central Nervous System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine group

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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 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.

Group Type: PLACEBO_COMPARATOR

Normal saline group

Intervention Type: DRUG

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.

Interventions

Dexmedetomidine

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.

Intervention Type: DRUG

Normal saline group

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.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine hydrochloride; 0.9% Sodium Chloride

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-Xin Zhou, MD

Role: STUDY_CHAIR

Capital Medical University

Locations

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34863109 (View on PubMed)

Other Identifiers

KY2019-091-02A

Identifier Type: -

Identifier Source: org_study_id