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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02208505

Enrollment

168

Registered

2014-08-05

Start date

2014-02-28

Completion date

2015-12-31

Last updated

2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy

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.

Interventions

DRUGDexmedetomidine + 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

DRUGRemifentanil-high dose

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Incidence of coughing during emergence from general anesthesia	from 5min before extubation to 5min after extubation

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
quality of recovery from anesthesia	upto 1day after surgery	using Quality of Recovery-40 questionnaire, evaluate the recovery status of patient from general anesthesia

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026