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

Thyroidectomy Clinical Trial

Official title:

Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion During Emergence in Adults After Thyroidectomy: Comparison With High-dose Remifentanil Infusion Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208505
• Other study ID #: 3-2013-0192`
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2014
• Last updated: October 17, 2017
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroidectomy

Intervention

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
• Remifentanil-high dose
maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)

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
Other	quality of recovery from anesthesia	using Quality of Recovery-40 questionnaire, evaluate the recovery status of patient from general anesthesia	upto 1day after surgery
Primary	Incidence of coughing during emergence from general anesthesia		from 5min before extubation to 5min after extubation
Secondary	side effect of remifentanil	comparison of the incidence of delayed awakening, post-operative nausea/vomiting, consumption of pain killer	up to 1 day after surgery