NCT02826746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

July 6, 2016

Last Update Submit

April 3, 2019

Conditions

Thyroid Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Throat pain

    pain assessment using visual analog scale

    Up to 48 hours after surgery end

Secondary Outcomes (1)

  • Fentanyl dose in recovery room

    Up to 30 minutes after surgery end

Study Arms (2)

Magnesium group

EXPERIMENTAL

intravenous administration of Magnesium Sulfate

Drug: Magnesium Sulfate

Control group

PLACEBO COMPARATOR

intravenous administration of normal saline

Drug: Normal saline

Interventions

Magnesium SulfateDRUG

adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h

Magnesium group
Normal salineDRUG

the same bolus and infusion volumes of normal saline

Control group

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Thyroidectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, Seoum, South Korea

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

KR(1)