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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Thyroidectomy

Treatments: Drug: Remifentanil-high dose; Drug: Dexmedetomidine + Remifentanil-low dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02208505

3-2013-0192'

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 2 patient groups

Dexmedetomidine

Experimental group

Description:

we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml).

Treatment:

Drug: Dexmedetomidine + Remifentanil-low dose

Remifentanil

Active Comparator group

Description:

we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone.

Treatment:

Drug: Remifentanil-high dose