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The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery

NCT ID: NCT01513772

Last Updated: 2012-08-09

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-08-31

Brief Summary

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The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery

Detailed Description

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Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery.

Conditions

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Airway Extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Normal saline 0.9%

Intervention Type DRUG

Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation

Dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation

Interventions

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Dexmedetomidine

Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation

Intervention Type DRUG

Normal saline 0.9%

Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age ≥ 20,
* ASA class I and II,
* nasal surgery

Exclusion Criteria

* bradycardia (\< 45 bpm),
* heart block,
* liver failure,
* renal failure,
* uncontrolled hypertension,
* body mass index ≥ 30 kg/m2
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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So Yeon Kim

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2011-0742

Identifier Type: -

Identifier Source: org_study_id