The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

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

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2020-04-14

Brief Summary

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Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In brain tumor resection craniotomy, it is proven to be effective in improving postoperative hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives postoperative pain. In addition, many animal experiments show that DEX inhibits the proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral focal ischemic region (penumbra). However, the neuroprotective effects were never investigated clinically in patients undergoing brain tumor resection surgery.

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Detailed Description

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Conditions

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Brain Tumor Cerebrovascular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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DEX

Intraoperative intravenous infusion of dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Intraoperative dexmedetomidine infusion

Control

Intraoperative intravenous infusion of 0.9% saline

Group Type PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Intraoperative dexmedetomidine infusion

Interventions

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Dexmedetomidine

Intraoperative dexmedetomidine infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery
* age between 20 to 80 yr

Exclusion Criteria

* Fever, elevated white blood cell or C-reactive protein
* Impaired liver function, eg. AST or ALT \>100; liver cirrhosis \> Child B class
* Impaired renal function, cGFR\< 60 ml/min/1.73 m2
* Cardiac dysfunction, such as heart failure \> NYHA class II

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No