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

Coughing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774305
• Other study ID #: 3-2012-0142
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2012
• Last updated: January 13, 2014
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coughing

Intervention

Drug:
• Dexmedetomidine
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.
• Saline
We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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