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

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.

Study Overview

• Status: Completed
• Conditions: Thyroidectomy
• Intervention / Treatment: Drug: Dexmedetomidine + Remifentanil-low dose; Drug: Remifentanil-high dose

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-720
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml).	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; Other Names: Precedex
Active Comparator: Remifentanil; we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone.	Drug: Remifentanil-high dose; maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml); Other Names: Ultiva

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Jeong Soo Lee, Yonsei University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: August 3, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: 3-2013-0192'