Back to resultsEffect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy
Primary Purpose
Thyroid Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Thyroidectomy
Exclusion Criteria:
- Allergy to magnesium
- Chronic pain
- Chronic opioid use
- Chronic NSAID use
- Renal dysfunction
- Liver dysfunction
- Cardiac arrythmia
- Seizure
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium group
Control group
Arm Description
intravenous administration of Magnesium Sulfate
intravenous administration of normal saline
Outcomes
Primary Outcome Measures
Throat pain
pain assessment using visual analog scale
Secondary Outcome Measures
Fentanyl dose in recovery room
Full Information
NCT ID
NCT02826746
First Posted
July 6, 2016
Last Updated
April 3, 2019
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02826746
Brief Title
Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the effect of intravenous magnesium on postoperative throat pain after thyroidectomy.
The secondary purpose of this study is to investigate the effect of intravenous magnesium on total dose of fentanyl in recovery room after thyroidectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium group
Arm Type
Experimental
Arm Description
intravenous administration of Magnesium Sulfate
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
intravenous administration of normal saline
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
the same bolus and infusion volumes of normal saline
Primary Outcome Measure Information:
Title
Throat pain
Description
pain assessment using visual analog scale
Time Frame
Up to 48 hours after surgery end
Secondary Outcome Measure Information:
Title
Fentanyl dose in recovery room
Time Frame
Up to 30 minutes after surgery end
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Thyroidectomy
Exclusion Criteria:
Allergy to magnesium
Chronic pain
Chronic opioid use
Chronic NSAID use
Renal dysfunction
Liver dysfunction
Cardiac arrythmia
Seizure
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
State/Province
Seoum
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy
We'll reach out to this number within 24 hrs