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

Phase 4

Completed

• Conditions: Coughing
• Interventions: Drug: Saline; Drug: Dexmedetomidine

• Registration Number: NCT01774305
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-22
• Primary Completion: 2013-01
• Study First Submitted QC: 2013-01-19
• Study First Posted: 2013-01-23
• Study Completion: 2013-06
• Results First Submitted: 2013-06-17
• Results First Submitted QC: 2013-06-17
• Results First Posted: 2013-08-22
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-13
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	Saline	We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
dexmedetomidine	Dexmedetomidine	We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.

Primary Outcome Measures

Name	Time	Method
Coughing Grade	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

Name	Time	Method
Emergence Time	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.

Trial Locations

Locations (1)

Gangnam severance hospital; 🇰🇷 Seoul, Korea, Republic of