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Completed

NCT Number: NCT01774305

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

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.

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Key information

Conditions

Coughing Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

Saline

Drug

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

Other names: Normal saline

Primary outcomes

  1. Coughing Grade

    Time frame: from the time of eye opening to 5 min after extubation

    The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).

Secondary outcomes

  1. Emergence Time

    Time frame: from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)

    The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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