Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Capital Medical University

Status: Enrolling

Conditions: Delirium; Dexmedetomidine; Awake Craniotomy

Treatments: Drug: Dexmedetomidine; Drug: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05195034

2022-01-04

Details and patient eligibility

About

Postoperative delirium (POD) is a common complication, and the incidence of POD ranges from 10% to 60%. Previous studies suggested that frontal approach and tumor located at the temporal lobe were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing awake craniotomies are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine (DEX) on POD for patients undergoing awake craniotomies remains unclear. The purpose of this study was to investigate the effect of DEX on POD in patients undergoing awake craniotomies.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing selective awake craniotomies.
• Age ≥18 years.
• Obtain written informed consent.

Exclusion criteria

• 1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18).
• 2.Preoperative psychotropic medication within one year.
• 3.BMI≤18 or ≥30 Kg/ m2
• 4.Pregnant or lactating women.
• 5.History of traumatic brain injury or neurosurgery.
• 6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
• 7.Severe hepatic or renal dysfunction.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 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