Back to resultsA Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
Primary Purpose
Post Operative Sore Throat
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine infusion
remifentanil infusion
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Sore Throat
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status classification I and II
- Undergoing lumbar spine surgery in prone position
Exclusion Criteria:
- Pre-existing sore throat, hoarseness, or upper respiratory tract infection
- Allergy to the study drugs
- Anticipated difficult airways
- More than two attempts at intubation
Sites / Locations
- Eun kyung ChoiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
dexmedetomidine infusion group
remifentanil infusion group
Arm Description
dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery
remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery
Outcomes
Primary Outcome Measures
incidence of postoperative sore throat at rest
0=none; 1=occur
incidence of postoperative sore throat at swallowing
0=none; 1=occur
severity of postoperative sore throat at rest
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
severity of postoperative sore throat at swallowing
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Secondary Outcome Measures
Full Information
NCT ID
NCT05345574
First Posted
April 19, 2022
Last Updated
April 19, 2022
Sponsor
Yeungnam University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05345574
Brief Title
A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
Official Title
The Effect of Dexmedetomidine and Remifentanil Infusion on Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2018 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Sore Throat
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine infusion group
Arm Type
Active Comparator
Arm Description
dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery
Arm Title
remifentanil infusion group
Arm Type
Active Comparator
Arm Description
remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine infusion
Intervention Description
dexmedetomidine as anaesthetic adjuvant
Intervention Type
Drug
Intervention Name(s)
remifentanil infusion
Intervention Description
remifentanil as anaesthetic adjuvant
Primary Outcome Measure Information:
Title
incidence of postoperative sore throat at rest
Description
0=none; 1=occur
Time Frame
1 hour after surgery
Title
incidence of postoperative sore throat at swallowing
Description
0=none; 1=occur
Time Frame
1 hour after surgery
Title
severity of postoperative sore throat at rest
Description
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Time Frame
1 hour after surgery
Title
severity of postoperative sore throat at swallowing
Description
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Time Frame
1 hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status classification I and II
Undergoing lumbar spine surgery in prone position
Exclusion Criteria:
Pre-existing sore throat, hoarseness, or upper respiratory tract infection
Allergy to the study drugs
Anticipated difficult airways
More than two attempts at intubation
Facility Information:
Facility Name
Eun kyung Choi
City
Daegu
State/Province
Korea (the Republic Of)
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun kyung Choi, MD,phD
Phone
+82-53-620-3361
Email
zzini0527@naver.com
12. IPD Sharing Statement
Learn more about this trial
A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
We'll reach out to this number within 24 hrs