Skip to main content
OpenTrials
Completed

NCT Number: NCT02208505

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroidectomy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam severance hospital

Seoul, 135-720, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine + Remifentanil-low dose

Drug

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

Other names: Precedex

Remifentanil-high dose

Drug

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

Other names: Ultiva

Primary outcomes

  1. Incidence of coughing during emergence from general anesthesia

    Time frame: from 5min before extubation to 5min after extubation

Secondary outcomes

  1. side effect of remifentanil

    Time frame: up to 1 day after surgery

    comparison of the incidence of delayed awakening, post-operative nausea/vomiting, consumption of pain killer

Other outcomes

  1. quality of recovery from anesthesia

    Time frame: upto 1day after surgery

    using Quality of Recovery-40 questionnaire, evaluate the recovery status of patient from general anesthesia

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2014
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.