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

November 23, 2015 updated by: Min Su, First Affiliated Hospital of Chongqing Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

118

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yanping Zhang, Master
  • Phone Number: 023-89011061
  • Email: 398254227@qq.com

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • The First Affliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D group (dexmedetomidine)
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.
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.
Active Comparator: C group (saline)
The patients received equal volume normal saline by intravenous infusion at the beginning of the surgery,and continued till end of surgery.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of coughing
Time Frame: within 48 hours postoperatively
coughing will be observed
within 48 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYYYMZK-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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