A Postoperative Sore Throat After Thyroidectomy

January 13, 2019 updated by: Eun Kyung Choi, Yeungnam University College of Medicine

The Effect of Dexmedetomidine and Remifentanil on the Postoperative Sore Throat After Thyroidectomy

This study was performed to compare the effect on of a postoperative sore throat between dexmedetomidine and remifentanil in patients undergoing thyroidectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Korea (the Republic Of)
      • Daegu, Korea (the Republic Of), Korea, Republic of, 41944
        • Eun kyung Choi

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who scheduled primary thyroidectomy were enrolled and their physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria:

  • Patients with respiratory tract disease, previous head, and neck surgery, preexisting steroid or non-steroidal anti-inflammatory drug use, and known or suspected 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dexmedetomidine infusion group
dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery
Drug: dexmedetomidine infusion group
dexmedetomidine as anaesthetic adjuvant
Active Comparator: remifentanil infusion group
remifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5~2.5 ng/ml) during the surgery
Drug: remifentanil infusion group
remifentanil as anaesthetic adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postoperative sore throat at rest
Time Frame: 6 hours after surgery
0=none; 1=occur
6 hours after surgery
incidence of postoperative sore throat at swallowing
Time Frame: 6 hours after surgery
0=none; 1=occur
6 hours after surgery
severity of postoperative sore throat at rest
Time Frame: 6 hours after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
6 hours after surgery
severity of postoperative sore throat at swallowing
Time Frame: 6 hours after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
6 hours after surgery

Collaborators and Investigators

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

Sponsor

Yeungnam University College of Medicine

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 (Actual)

July 5, 2017

Primary Completion (Actual)

July 3, 2018

Study Completion (Actual)

July 25, 2018

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 13, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 13, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YUMC 2017-03-037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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