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

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

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2025-12-30

Brief Summary

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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.

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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 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 0.4ug/kg/h intraoperatively.

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 0.4ug/kg/h intraoperatively.

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 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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No