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

C

Chongqing Medical University

Status and phase

Unknown
Phase 4

Conditions

Coughing Response
General Anesthesia
Thyroid Surgery

Treatments

Drug: normal saline
Drug: Dexmeditomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02613806
CYYYMZK-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

118 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

118 participants in 2 patient groups

D group (dexmedetomidine)
Experimental group
Description:
Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion with microperfusion pump at the beginning of the surgery,and continued till end of surgery.
Treatment:
Drug: Dexmeditomidine
C group (saline)
Active Comparator group
Description:
The patients received equal volume normal saline by intravenous infusion at the beginning of the surgery,and continued till end of surgery.
Treatment:
Drug: normal saline

Trial contacts and locations

1

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Central trial contact

Yanping Zhang, Master

Data sourced from clinicaltrials.gov

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