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

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ClinicalTrials.gov Identifier: NCT01774305
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : August 22, 2013
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Jeong Soo Lee, Yonsei University

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.


Condition or disease Intervention/treatment Phase
Coughing Drug: Dexmedetomidine Drug: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
Study Start Date : December 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: dexmedetomidine
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
Drug: Dexmedetomidine
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.
Other Name: Precedex

Placebo Comparator: saline
We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Drug: Saline
We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
Other Name: Normal saline




Primary Outcome Measures :
  1. Coughing Grade [ Time Frame: from the time of eye opening to 5 min after extubation ]
    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 :
  1. Emergence Time [ Time Frame: from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min) ]
    The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774305


Locations
Korea, Republic of
Gangnam severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeong Soo Lee, Yonsei university college of medicine, Yonsei University
ClinicalTrials.gov Identifier: NCT01774305     History of Changes
Other Study ID Numbers: 3-2012-0142
First Posted: January 23, 2013    Key Record Dates
Results First Posted: August 22, 2013
Last Update Posted: February 10, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action