- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826746
Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy
April 3, 2019 updated by: Ji Eun Kim, Ajou University School of Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
Seoum
-
Suwon, Seoum, Korea, Republic of
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
-
-
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 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Thyroidectomy
Exclusion Criteria:
- Allergy to magnesium
- Chronic pain
- Chronic opioid use
- Chronic NSAID use
- Renal dysfunction
- Liver dysfunction
- Cardiac arrythmia
- Seizure
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Magnesium group
intravenous administration of Magnesium Sulfate
|
adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h
|
Placebo Comparator: Control group
intravenous administration of normal saline
|
the same bolus and infusion volumes of normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Throat pain
Time Frame: Up to 48 hours after surgery end
|
pain assessment using visual analog scale
|
Up to 48 hours after surgery end
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fentanyl dose in recovery room
Time Frame: Up to 30 minutes after surgery end
|
Up to 30 minutes after surgery end
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 1, 2016
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
July 6, 2016
First Submitted That Met QC Criteria
July 7, 2016
First Posted (Estimate)
July 11, 2016
Study Record Updates
Last Update Posted (Actual)
April 5, 2019
Last Update Submitted That Met QC Criteria
April 3, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Thyroid Diseases
- Head and Neck Neoplasms
- Thyroid Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- AJIRB-MED-CT4-16-089
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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