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

• 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: Yonsei University
• Information provided by (Responsible Party): Jeong Soo Lee, Yonsei University

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Korea, Republic of

Gangnam severance hospital

Seoul, Korea, Republic of

Sponsors and Collaborators

Yonsei University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jeong Soo Lee, Yonsei university college of medicine, Yonsei University
• ClinicalTrials.gov Identifier: NCT01774305
• Other Study ID Numbers: 3-2012-0142
• First Posted: January 23, 2013
• Results First Posted: August 22, 2013
• Last Update Posted: February 10, 2014
• Last Verified: January 2014

Additional relevant MeSH terms:

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; 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