Back to resultsComparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial
Primary Purpose
Post Operative Sore Throat
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Sore Throat focused on measuring Magnesium, Post operative sore throat, Prone position, Tracheal intubation
Eligibility Criteria
Inclusion Criteria:
- ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation
Exclusion Criteria:
- preexisting hoarseness or sore throat, upper respiratory tract infection
- steroid therapy or immunocompromised patients
- chronic treatment with calcium channel blocker or magnesium
- allergy to magnesium sulphate
- Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation
- fail to tracheal intubation at first trial
- reduced kidney function
- Diabetes mellitus
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Magnesium group
Dexamethasone group
Arm Description
Outcomes
Primary Outcome Measures
The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation
Incidence of post operative sore throat Severity of post operative sore throat (10 cm-visual analogue scale ) Incidence of post operative hoarseness Severity of post operative hoarseness ( four-graded scale, 0= no hoarseness, 1= mild hoarseness, 2= severe hoarseness, 3= aphonia)
Secondary Outcome Measures
The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation
Incidence of post operative sore throat Severity of post operative sore throat (10 cm-visual analogue scale ) Incidence of post operative hoarseness Severity of post operative hoarseness ( four-graded scale, 0= no hoarseness, 1= mild hoarseness, 2= severe hoarseness, 3= aphonia)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01923831
Brief Title
Comparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Sore Throat
Keywords
Magnesium, Post operative sore throat, Prone position, Tracheal intubation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium group
Arm Type
Experimental
Arm Title
Dexamethasone group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Magnesium sulfate 30 mg kg-1 was infused in 100mL normal saline for 10 minutes immediately before anesthesia induction. After tracheal intubation, normal saline 1.6mL ( equivalent volume as Dexamethasone 8mg) was injected, and magnesium sulfate was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Normal saline 100mL was infused for 10 minutes immediately before anesthesia induction. After tracheal intubation, dexamethasone 8mg was injected, and normal saline was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)
Primary Outcome Measure Information:
Title
The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation
Description
Incidence of post operative sore throat Severity of post operative sore throat (10 cm-visual analogue scale ) Incidence of post operative hoarseness Severity of post operative hoarseness ( four-graded scale, 0= no hoarseness, 1= mild hoarseness, 2= severe hoarseness, 3= aphonia)
Time Frame
Change of post operative sore throat level from 1 to 48 hours after surgery
Secondary Outcome Measure Information:
Title
The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation
Description
Incidence of post operative sore throat Severity of post operative sore throat (10 cm-visual analogue scale ) Incidence of post operative hoarseness Severity of post operative hoarseness ( four-graded scale, 0= no hoarseness, 1= mild hoarseness, 2= severe hoarseness, 3= aphonia)
Time Frame
Change of post operative sore throat level from 1 to 48 hours 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:
ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation
Exclusion Criteria:
preexisting hoarseness or sore throat, upper respiratory tract infection
steroid therapy or immunocompromised patients
chronic treatment with calcium channel blocker or magnesium
allergy to magnesium sulphate
Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation
fail to tracheal intubation at first trial
reduced kidney function
Diabetes mellitus
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial
We'll reach out to this number within 24 hrs