Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thyroidectomy
Intervention: Dexmedetomidine + Remifentanil-low dose (Drug); Remifentanil-high dose (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Yonsei University Official(s) and/or principal investigator(s): Jeong Soo Lee, Principal Investigator, Affiliation: Yonsei University
Overall contact: Jeong Soo Lee, Phone: 82-2-2019-6092, Email: ration99@yuhs.ac
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of coughing during emergence from general anesthesia
Secondary outcome: side effect of remifentanil
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jeong Soo Lee, Phone: 82-2-2019-6092, Email: ration99@yuhs.ac
Gangnam severance hospital, Seoul 135-720, Korea, Republic of; Recruiting
Additional Information
Starting date: February 2014
Last updated: June 25, 2015
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