Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
This study is currently recruiting participants.
Verified January 2013 by Yonsei University
Sponsor:
Yonsei University
Information provided by (Responsible Party):
Jeong Soo Lee, Yonsei University
ClinicalTrials.gov Identifier:
NCT01774305
First received: December 22, 2012
Last updated: January 19, 2013
Last verified: January 2013
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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.
- haemodynamic stability during emergence [ Time Frame: from sevoflurane discontinuation, up to the time of leaving the postanesthetic recovery room (up to 30 min in PACU) ] [ Designated as safety issue: No ]mean blood pressure,heart rate will be recorded at the time from sevoflurane discontinuation, up to 30 min in PACU (Check systolic/diastolic/mean arterial blood pressure and pulse rate at every 10 min)
| Estimated Enrollment: | 142 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated 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 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 |
| Last Updated: | January 19, 2013 |
| 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 May 19, 2013