Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02826746

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Neoplasms	Drug: Magnesium Sulfate Drug: Normal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Magnesium group intravenous administration of Magnesium Sulfate	Drug: 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	Drug: Normal saline the same bolus and infusion volumes of normal saline

Arm

Intervention/Treatment

Experimental: Magnesium group

intravenous administration of Magnesium Sulfate

Drug: 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

Drug: Normal saline

the same bolus and infusion volumes of normal saline

Outcome Measures

Primary Outcome Measures

Throat pain [Up to 48 hours after surgery end]
pain assessment using visual analog scale

Secondary Outcome Measures

Fentanyl dose in recovery room [Up to 30 minutes after surgery end]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Thyroidectomy

Exclusion Criteria:

Allergy to magnesium
Chronic pain
Chronic opioid use
Chronic NSAID use
Renal dysfunction
Liver dysfunction
Cardiac arrythmia
Seizure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine	Suwon	Seoum	Korea, Republic of

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji Eun Kim, Assistant professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT02826746

Other Study ID Numbers:

AJIRB-MED-CT4-16-089

First Posted:

Jul 11, 2016

Last Update Posted:

Apr 5, 2019

Last Verified:

Apr 1, 2019

Additional relevant MeSH terms:

Thyroid Neoplasms

Magnesium Sulfate

Study Results

No Results Posted as of Apr 5, 2019