Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion

Phase 4

Completed

• Conditions: Thyroidectomy
• Interventions: Drug: Dexmedetomidine + Remifentanil-low dose; Drug: Remifentanil-high dose

• Registration Number: NCT02208505
• Lead Sponsor: Yonsei University

Brief Summary

After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Several studies have shown that the single-dose of dexmedetomidine is effective for reducing cough and agitation during emergence from general anesthesia.

To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose remifentanil infusion during emergence from general anaesthesia could reduce coughing as good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and reduction of side effect of remifentanil using non-inferiority trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-08-03
• Study First Posted: 2014-08-05
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Thyroid disease undergoing thyroidectomy
• age 20-65
• Amerian society of anesthesgiologist class 1 or 2

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Exclusion Criteria

• chronic cough
• difficult intubation
• liver disease
• uncontrolled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine + Remifentanil-low dose	we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml).
Remifentanil	Remifentanil-high dose	we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone.

Primary Outcome Measures

Name	Time	Method
Incidence of coughing during emergence from general anesthesia	from 5min before extubation to 5min after extubation

Secondary Outcome Measures

Name	Time	Method
side effect of remifentanil	up to 1 day after surgery	comparison of the incidence of delayed awakening, post-operative nausea/vomiting, consumption of pain killer

Trial Locations

Locations (1)

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