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

NCT02208505 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2017-10-18

No results posted yet for this study

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.

Conditions

  • Thyroidectomy

Interventions

DRUG

Dexmedetomidine + Remifentanil-low dose

single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery

DRUG

Remifentanil-high dose

maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Jeong Soo Lee · Yonsei University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-07-31
Completion
2015-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02208505 on ClinicalTrials.gov