Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients

Capital Medical University

Status: Enrolling

Conditions: Dexmedetomidine; Postoperative Delirium

Treatments: Drug: Dexmedetomidine; Drug: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05168280

2021-12-05

Details and patient eligibility

About

Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.

Enrollment: 420 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing selective craniotomy.
• Age ≥65 years.
• Obtain written informed consent.

Exclusion criteria

• Operation time less than 2 hours.
• Refusal to provide written informed consent.
• Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
• Allergic to the study drug.
• Body mass index ≤18 or ≥ 30 kg/m2.
• History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
• History of traumatic brain injury or neurosurgery.
• Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
• Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
• The functional neurosurgery.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 2 patient groups, including a placebo group

DEX group

Active Comparator group

Description:

The DEX group patients will be received dexmedetomidine intraoperatively.

Treatment:

Drug: Dexmedetomidine

Placebo group

Placebo Comparator group

Description:

The placebo group patients will be received 0.9% saline intraoperatively.

Treatment:

Drug: 0.9% saline