Coughing Clinical Trial
Official title:
Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
Verified date | January 2014 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 141 |
Est. completion date | June 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gangnam severance hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coughing Grade | 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). | from the time of eye opening to 5 min after extubation | No |
Secondary | Emergence Time | The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command. | from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min) | No |
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