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Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy

Primary Purpose

Coughing

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coughing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status 1 or 2 patients patients scheduled for thyroidectomy

Exclusion Criteria:

  • Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean

Sites / Locations

  • Gangnam severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dexmedetomidine

saline

Arm Description

We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.

We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.

Outcomes

Primary Outcome Measures

Coughing Grade
The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).

Secondary Outcome Measures

Emergence Time
The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.

Full Information

First Posted
December 22, 2012
Last Updated
January 13, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01774305
Brief Title
Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
Official Title
Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

5. Study Description

Brief Summary
Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during emergence from anaesthesia. In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of surgery reduces coughing during extubation after thyroidectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coughing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine
Arm Type
Experimental
Arm Description
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal saline
Intervention Description
We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
Primary Outcome Measure Information:
Title
Coughing Grade
Description
The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).
Time Frame
from the time of eye opening to 5 min after extubation
Secondary Outcome Measure Information:
Title
Emergence Time
Description
The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.
Time Frame
from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status 1 or 2 patients patients scheduled for thyroidectomy Exclusion Criteria: Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean
Facility Information:
Facility Name
Gangnam severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25523837
Citation
Lee JS, Choi SH, Kang YR, Kim Y, Shim YH. Efficacy of a single dose of dexmedetomidine for cough suppression during anesthetic emergence: a randomized controlled trial. Can J Anaesth. 2015 Apr;62(4):392-8. doi: 10.1007/s12630-014-0295-6. Epub 2014 Dec 19.
Results Reference
derived

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Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy

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