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

NCT02208505 | Completed Phase 4

• 1 other identifier: 3-2013-0192'
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of coughing during emergence from general anesthesia

  from 5min before extubation to 5min after extubation

Secondary Outcomes (1)

• side effect of remifentanil

  up to 1 day after surgery

Other Outcomes (1)

• quality of recovery from anesthesia

  upto 1day after surgery

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine + Remifentanil-low dose

Remifentanil

ACTIVE COMPARATOR

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

Drug: Remifentanil-high dose

Interventions

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

Also known as: Precedex

Dexmedetomidine

Remifentanil-high dose DRUG

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

Also known as: Ultiva

Remifentanil

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Gangnam severance hospital

Seoul, 135-720, South Korea

Location

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• Jeong Soo Lee

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: August 5, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

KR (1)