Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dexmedetomidine Delirium Awake Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DEX group

The DEX group patients will be received dexmedetomidine intraoperatively.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with continuous infusion at a rate of 0.2 µg/kg/hour until the end of dural closure.

Placebo group

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

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

The 0.9% saline is administered with the same volume at the same speed as the other group.

Interventions

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Dexmedetomidine

The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with continuous infusion at a rate of 0.2 µg/kg/hour until the end of dural closure.

Intervention Type DRUG

0.9% saline

The 0.9% saline is administered with the same volume at the same speed as the other group.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No