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A Postoperative Sore Throat After Thyroidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03805568
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eun Kyung Choi, Yeungnam University College of Medicine

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

Condition or disease Intervention/treatment Phase
Post Operative Sore Throat Drug: dexmedetomidine infusion group Drug: remifentanil infusion group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Dexmedetomidine and Remifentanil on the Postoperative Sore Throat After Thyroidectomy
Actual Study Start Date : July 5, 2017
Actual Primary Completion Date : July 3, 2018
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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




Primary Outcome Measures :
  1. incidence of postoperative sore throat at rest [ Time Frame: 6 hours after surgery ]
    0=none; 1=occur

  2. incidence of postoperative sore throat at swallowing [ Time Frame: 6 hours after surgery ]
    0=none; 1=occur

  3. severity of postoperative sore throat at rest [ Time Frame: 6 hours after surgery ]
    4-point scale (0=none; 1=mild; 2=moderate; 3=severe)

  4. severity of postoperative sore throat at swallowing [ Time Frame: 6 hours after surgery ]
    4-point scale (0=none; 1=mild; 2=moderate; 3=severe)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805568


Locations
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Korea, Republic of
Eun kyung Choi
Daegu, Korea (the Republic Of), Korea, Republic of, 41944
Sponsors and Collaborators
Yeungnam University College of Medicine

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Responsible Party: Eun Kyung Choi, Professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT03805568     History of Changes
Other Study ID Numbers: YUMC 2017-03-037
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eun Kyung Choi, Yeungnam University College of Medicine:
postoperative sore throat
dexmedetomidine
remifentanil
thyroidectomy

Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics