NCT01774305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2012

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 22, 2013

Completed
Last Updated

February 10, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

December 22, 2012

Results QC Date

June 17, 2013

Last Update Submit

January 13, 2014

Conditions

Coughing

Outcome Measures

Primary Outcomes (1)

  • 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).

    from the time of eye opening to 5 min after extubation

Secondary Outcomes (1)

  • Emergence Time

    from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

DexmedetomidineDRUG

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

Also known as: Precedex
dexmedetomidine
SalineDRUG

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

Also known as: Normal saline
saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam severance hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25523837DERIVED

MeSH Terms

Conditions

Cough

Interventions

DexmedetomidineSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Jeongsoo Lee
Organization
Yonsei Univ. Health System, Gangnam Severance Hospital
ration99@yuhs.ac
+82-2-2019-6092

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Yonsei university college of medicine

Study Record Dates

First Submitted

December 22, 2012

First Posted

January 23, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

February 10, 2014

Results First Posted

August 22, 2013

Record last verified: 2014-01

Locations

KR(1)