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

Primary Purpose

Coughing Response, Thyroid Surgery, General Anesthesia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmeditomidine
normal saline
Sponsored by
First Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coughing Response focused on measuring Dexmedetomidine, Coughing Response, Postoperative Recovery Quality, Thyroid Surgery

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affliated Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

D group (dexmedetomidine)

C group (saline)

Arm 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.

The patients received equal volume normal saline by intravenous infusion at the beginning of the surgery,and continued till end of surgery.

Outcomes

Primary Outcome Measures

the incidence of coughing
coughing will be observed

Secondary Outcome Measures

coughing on a four-point scale
coughing on a four-point scale will be measured within 48 hours postoperatively
the eyes opening time
the eyes opening time will be observed
the time of extubation
the time of extubation will be recorded
visual analogue scale (VAS)
visual analogue scale will be measured at 30 minutes after extubation
sedation-agitation scale(SAS)
sedation-agitation scale will be measured at 30 minutes after extubation

Full Information

First Posted
November 23, 2015
Last Updated
November 23, 2015
Sponsor
First Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02613806
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Chongqing Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coughing Response, Thyroid Surgery, General Anesthesia
Keywords
Dexmedetomidine, Coughing Response, Postoperative Recovery Quality, Thyroid Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D group (dexmedetomidine)
Arm Type
Experimental
Arm 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.
Arm Title
C group (saline)
Arm Type
Active Comparator
Arm Description
The patients received equal volume normal saline by intravenous infusion at the beginning of the surgery,and continued till end of surgery.
Intervention Type
Drug
Intervention Name(s)
Dexmeditomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Isovolumetric normal saline will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.
Primary Outcome Measure Information:
Title
the incidence of coughing
Description
coughing will be observed
Time Frame
within 48 hours postoperatively
Secondary Outcome Measure Information:
Title
coughing on a four-point scale
Description
coughing on a four-point scale will be measured within 48 hours postoperatively
Time Frame
within 48 hours postoperatively
Title
the eyes opening time
Description
the eyes opening time will be observed
Time Frame
within 48 hours postoperatively
Title
the time of extubation
Description
the time of extubation will be recorded
Time Frame
within 48 hours postoperatively
Title
visual analogue scale (VAS)
Description
visual analogue scale will be measured at 30 minutes after extubation
Time Frame
at 30 minutes after extubation
Title
sedation-agitation scale(SAS)
Description
sedation-agitation scale will be measured at 30 minutes after extubation
Time Frame
at 30 minutes after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged from 18 to 65 years old American Society of Anesthesiologists (ASA) physical statusⅠor Ⅱ Diagnosed by B ultrasonic or tissue biopsy show that patients thyrophyma,thyroid cancer,thyroid nodule,etc,who need to accept thyroid surgery Exclusion Criteria: large goiter or hyperthyroidism Preoperative coughing caused by primary diseases of patients Ⅱdegrees above atrioventricular block Allergy to anesthesia History of diabetes Pregnant women Serious mental disease History of alcohol or drug abuse Severe heart renal or liver dysfunction The presence of an upper respiratory infection Asthma Anticipated difficult airway
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanping Zhang, Master
Phone
023-89011061
Email
398254227@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Min
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Min, MD.
Phone
+86-23-89011068
Email
ms89011068@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
17379129
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. Erratum In: J Clin Anesth. 2007 Jun;19(4):323.
Results Reference
background
PubMed Identifier
20039221
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.
Results Reference
background
PubMed Identifier
16402208
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.
Results Reference
background
PubMed Identifier
11046225
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.
Results Reference
background
PubMed Identifier
22824921
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.
Results Reference
background
PubMed Identifier
25132201
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.
Results Reference
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Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General Anesthesia

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