Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

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

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2022-01-28

Brief Summary

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Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.

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Detailed Description

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Conditions

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Dexmedetomidine Postoperative Delirium

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 will receives dexmedetomidine intraoperative.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Ten minutes after anesthesia induction and endotracheal intubation, patients assigned to dexmedetomidine group were given a loading dose of dexmedetomidine 0.6 μg/kg over 10 minutes, followed by continuous infusion at a rate of 0.4 μg/kg/h until the start of dural closure.

Placebo group

The placebo group will receives 0.9% saline intraoperative.

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

Ten minutes after anesthesia induction and endotracheal intubation, patients assigned to dexmedetomidine group were given a loading dose of dexmedetomidine 0.6 μg/kg over 10 minutes, followed by continuous infusion at a rate of 0.4 μg/kg/h until the start of dural closure.

Intervention Type DRUG

0.9% saline

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 frontotemporal tumor resection.
* Age ≥18 years.
* Obtain written informed consent.

Exclusion Criteria

* Refusal to provide written informed consent.
* Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
* Allergic to the study drug.
* History of psychotropic drugs within past 30 days.
* Pregnant or lactating women.
* 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 hepatic or renal dysfunction.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No