Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General Anesthesia

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02613806
• Other study ID #: CYYYMZK-08
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 23, 2015
• Last updated: November 23, 2015
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Yanping Zhang, Master
• Phone: 023-89011061
• Email: 398254227[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coughing Response
• General Anesthesia
• Thyroid Diseases
• Thyroid Surgery

Intervention

Drug:
• Dexmeditomidine
Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.
• normal saline
Isovolumetric normal saline will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.

Locations

Country	Name	City	State
China	The First Affliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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

Outcome

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