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Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion

NCT ID: NCT02208505

Last Updated: 2017-10-18

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

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

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After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Several studies have shown that the single-dose of dexmedetomidine is effective for reducing cough and agitation during emergence from general anesthesia.

To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose remifentanil infusion during emergence from general anaesthesia could reduce coughing as good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and reduction of side effect of remifentanil using non-inferiority trial.

Detailed Description

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Conditions

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Thyroidectomy

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

we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml).

Group Type EXPERIMENTAL

Dexmedetomidine + Remifentanil-low dose

Intervention Type DRUG

single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery

Remifentanil

we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone.

Group Type ACTIVE_COMPARATOR

Remifentanil-high dose

Intervention Type DRUG

maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)

Interventions

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Dexmedetomidine + Remifentanil-low dose

single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery

Intervention Type DRUG

Remifentanil-high dose

maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)

Intervention Type DRUG

Other Intervention Names

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Precedex Ultiva

Eligibility Criteria

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Inclusion Criteria

* Thyroid disease undergoing thyroidectomy
* age 20-65
* Amerian society of anesthesgiologist class 1 or 2

Exclusion Criteria

* chronic cough
* difficult intubation
* liver disease
* uncontrolled hypertension
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Jeong Soo Lee

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Soo Lee

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Gangnam severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2013-0192'

Identifier Type: -

Identifier Source: org_study_id