Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy

NCT ID: NCT01774305

Last Updated: 2014-02-10

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

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-06-30

Brief Summary

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Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during emergence from anaesthesia.

In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of surgery reduces coughing during extubation after thyroidectomy.

Detailed Description

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Conditions

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Coughing

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 dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.

saline

We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.

Interventions

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Dexmedetomidine

We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.

Intervention Type DRUG

Saline

We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.

Intervention Type DRUG

Other Intervention Names

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Precedex Normal saline

Eligibility Criteria

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Inclusion Criteria

* ASA physical status 1 or 2 patients patients scheduled for thyroidectomy

Exclusion Criteria

* Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Yonsei university college of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee JS, Choi SH, Kang YR, Kim Y, Shim YH. Efficacy of a single dose of dexmedetomidine for cough suppression during anesthetic emergence: a randomized controlled trial. Can J Anaesth. 2015 Apr;62(4):392-8. doi: 10.1007/s12630-014-0295-6. Epub 2014 Dec 19.

Reference Type DERIVED
PMID: 25523837 (View on PubMed)

Other Identifiers

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3-2012-0142

Identifier Type: -

Identifier Source: org_study_id

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