General Anesthesia Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 118 |
Est. completion date | December 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: 1. Aged from 18 to 65 years old 2. American Society of Anesthesiologists (ASA) physical status?or ? 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. ?degrees 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The First Affliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Chongqing Medical University |
China,
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. — View 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. Erratum in: J Clin Anesth. 2007 Jun;19(4):323. — View 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. — View Citation
Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. Review. — View 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. — View 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. Epub 2006 Jan 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the incidence of coughing | coughing will be observed | within 48 hours postoperatively | No |
Secondary | coughing on a four-point scale | coughing on a four-point scale will be measured within 48 hours postoperatively | within 48 hours postoperatively | No |
Secondary | the eyes opening time | the eyes opening time will be observed | within 48 hours postoperatively | No |
Secondary | the time of extubation | the time of extubation will be recorded | within 48 hours postoperatively | No |
Secondary | visual analogue scale (VAS) | visual analogue scale will be measured at 30 minutes after extubation | at 30 minutes after extubation | No |
Secondary | sedation-agitation scale(SAS) | sedation-agitation scale will be measured at 30 minutes after extubation | at 30 minutes after extubation | No |
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