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Dexmedetomidine to Prevent Agitation After Free Flap Surgery

NCT ID: NCT01904760

Last Updated: 2014-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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Reconstruction using microvascular free tissue flap has been an important management in patients with maxillofacial tumor. It is often characterised as long operation time, more traumatic and require restriction of patient's head movement postoperatively in order to prevent disruption of microvascular anastomosis. Agitation and delirium are common in patients with free flap surgery, which may lead to serious consequences such as self extubation, injury or even failure of the flap.

Dexmedetomidine is a sedative and co-analgesic drug with high specificity for α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on preventing delirium has not been proved.

The investigators hypothesized that the use of Dexmedetomidine would reduce emergence agitation and prevent delirium in patients after free flap surgery.

Detailed Description

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Conditions

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Agitation 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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dexmedetomidine

Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.

control

Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.

Group Type PLACEBO_COMPARATOR

Saline placebo

Intervention Type DRUG

Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day

Interventions

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Dexmedetomidine

Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.

Intervention Type DRUG

Saline placebo

Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

* patients undergoing selected maxillofacial surgery with free flap reconstruction
* American Society of Anesthesiologist(ASA) classification I and II

Exclusion Criteria

* bradycardia (\< 50 bpm)
* severe heart block
* low blood pressure(SBP\<80mmHg)
* Known allergy to alpha 2 agonists
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Yang Xudong

vice director of the department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School and Hospital of Stomatology

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PKUSSIRB-2012006

Identifier Type: -

Identifier Source: org_study_id