Clinical trial NCT02613806: Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General Anesthesia
Official title: Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General anesthesia---a Randomized Control Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coughing Response
Thyroid Surgery
General Anesthesia
Keywords: Dexmedetomidine
Coughing Response
Postoperative Recovery Quality
Thyroid Surgery
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coughing is a common adverse reaction of thyroid surgery,which could result in postoperative bleeding.Postoperative bleeding is a serious and potentially life-threatening complication，which could result in acute upper airway obstruction due to neck hematoma and increase the need for re-operation.The purpose of this study is to investigate whether dexmedetomidine can reduce the incidence of postoperative coughing and contribute to postoperative recovery in patients undergoing tyroid surgery with general anesthesia.

Detailed description: Thyroid surgery is a common clinical surgery,the incidence of postoperative coughing is up to 32.4%.Coughing response could result in postoperative bleeding,even cause respiratory tract obstruction,affect patients' postoperative recovery .Dexmedetomidine,an α2 adrenergic agonist,has hypnotic,analgesic, anxiolytic,antisympathetic effects,which could facilitate the sedation of patients while maintaining their consciousness and keep respiration and circulation stable .For these benefits,dexmedetomidine was widely used for general anesthesia.However,whether dexmedetomidine can reduce the incidence of postoperative coughing is unclear.Therefore,the investigators conduct this randomized controlled double-blind trial,to investigate the effects of dexmedetomidine on coughing and postoperative recovery quality in patients undergoing tyroid surgery with general anesthesia.

Eligibility criteria: Inclusion Criteria:

1. Aged from 18 to 65 years old
2. American Society of Anesthesiologists (ASA) physical statusⅠor Ⅱ
3. Diagnosed by B ultrasonic or tissue biopsy show that patients thyrophyma,thyroid cancer,thyroid nodule,etc,who need to accept thyroid surgery

Exclusion Criteria:

1. large goiter or hyperthyroidism
2. Preoperative coughing caused by primary diseases of patients
3. Ⅱdegrees above atrioventricular block
4. Allergy to anesthesia
5. History of diabetes
6. Pregnant women
7. Serious mental disease
8. History of alcohol or drug abuse
9. Severe heart renal or liver dysfunction
10. The presence of an upper respiratory infection
11. Asthma
12. Anticipated difficult airway

Primary outcomes:
measure: the incidence of coughing
timeFrame: within 48 hours postoperatively
Secondary outcomes:
measure: coughing on a four-point scale
timeFrame: within 48 hours postoperatively
measure: the eyes opening time
timeFrame: within 48 hours postoperatively
measure: the time of extubation
timeFrame: within 48 hours postoperatively
measure: visual analogue scale (VAS)
timeFrame: at 30 minutes after extubation
measure: sedation-agitation scale(SAS)
timeFrame: at 30 minutes after extubation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Su Min
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergese SD, Khabiri B, Roberts WD, Howie MB, McSweeney TD, Gerhardt MA. Dexmedetomidine for conscious sedation in difficult awake fiberoptic intubation cases. J Clin Anesth. 2007 Mar;19(2):141-4. doi: 10.1016/j.jclinane.2006.07.005.
citation: Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29.
citation: Kiray A, Naderi S, Ergur I, Korman E. Surgical anatomy of the internal branch of the superior laryngeal nerve. Eur Spine J. 2006 Sep;15(9):1320-5. doi: 10.1007/s00586-005-0006-7. Epub 2006 Jan 5.
citation: Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.
citation: Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.
citation: Ham SY, Kim JE, Park C, Shin MJ, Shim YH. Dexmedetomidine does not reduce emergence agitation in adults following orthognathic surgery. Acta Anaesthesiol Scand. 2014 Sep;58(8):955-60. doi: 10.1111/aas.12379.