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

This study has been completed.
Information provided by (Responsible Party):
Jeong Soo Lee, Yonsei University Identifier:
First received: December 22, 2012
Last updated: January 13, 2014
Last verified: January 2014

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.

Condition Intervention Phase
Drug: Dexmedetomidine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 141
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexmedetomidine
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
Drug: Dexmedetomidine
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.
Other Name: Precedex
Placebo Comparator: saline
We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Drug: Saline
We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
Other Name: Normal saline


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01774305

Korea, Republic of
Gangnam severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jeong Soo Lee, Yonsei university college of medicine, Yonsei University Identifier: NCT01774305     History of Changes
Other Study ID Numbers: 3-2012-0142
Study First Received: December 22, 2012
Results First Received: June 17, 2013
Last Updated: January 13, 2014

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017