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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeong Soo Lee, Yonsei University
ClinicalTrials.gov Identifier:
NCT01774305
First received: December 22, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Coughing
Drug: Dexmedetomidine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Coughing Grade [ Time Frame: from the time of eye opening to 5 min after extubation ] [ Designated as safety issue: No ]
    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 [ Time Frame: from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min) ] [ Designated as safety issue: No ]
    The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.


Enrollment: 141
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01774305

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

No publications provided

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
Study First Received: December 22, 2012
Results First Received: June 17, 2013
Last Updated: January 13, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 21, 2014