A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position

April 19, 2022 updated by: Eun Kyung Choi, Yeungnam University College of Medicine

The Effect of Dexmedetomidine and Remifentanil Infusion on Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position

This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

104

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, 42415
        • Recruiting
        • Eun kyung Choi
        • 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

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) physical status classification I and II
  2. Undergoing lumbar spine surgery in prone position

Exclusion Criteria:

  1. Pre-existing sore throat, hoarseness, or upper respiratory tract infection
  2. Allergy to the study drugs
  3. Anticipated difficult airways
  4. More than two attempts at intubation

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
  • 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
dexmedetomidine as anaesthetic adjuvant
ACTIVE_COMPARATOR: remifentanil infusion group
remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery
Drug: remifentanil infusion
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: 1 hour after surgery
0=none; 1=occur
1 hour after surgery
incidence of postoperative sore throat at swallowing
Time Frame: 1 hour after surgery
0=none; 1=occur
1 hour after surgery
severity of postoperative sore throat at rest
Time Frame: 1 hour after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
1 hour after surgery
severity of postoperative sore throat at swallowing
Time Frame: 1 hour after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
1 hour 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)

December 26, 2018

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (ACTUAL)

April 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YUMC 2018-09-029

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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