NCT03805568

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 7, 2019

Last Update Submit

January 13, 2019

Conditions

Post Operative Sore Throat

Keywords

postoperative sore throatdexmedetomidineremifentanilthyroidectomy

Outcome Measures

Primary Outcomes (4)

  • incidence of postoperative sore throat at rest

    0=none; 1=occur

    6 hours after surgery

  • incidence of postoperative sore throat at swallowing

    0=none; 1=occur

    6 hours after surgery

  • severity of postoperative sore throat at rest

    4-point scale (0=none; 1=mild; 2=moderate; 3=severe)

    6 hours after surgery

  • severity of postoperative sore throat at swallowing

    4-point scale (0=none; 1=mild; 2=moderate; 3=severe)

    6 hours after surgery

Study Arms (2)

dexmedetomidine infusion group

ACTIVE COMPARATOR

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

remifentanil infusion group

ACTIVE COMPARATOR

remifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5\~2.5 ng/ml) during the surgery

Drug: remifentanil infusion group

Interventions

dexmedetomidine infusion groupDRUG

dexmedetomidine as anaesthetic adjuvant

dexmedetomidine infusion group
remifentanil infusion groupDRUG

remifentanil as anaesthetic adjuvant

remifentanil infusion group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eun kyung Choi

Daegu, Korea (the Republic Of), 41944, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 15, 2019

Study Start

July 5, 2017

Primary Completion

July 3, 2018

Study Completion

July 25, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Locations

KR(1)