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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01923831
Enrollment
146
Registered
2013-08-16
Start date
2013-08-31
Completion date
2014-09-30
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Sore Throat

Keywords

Magnesium, Post operative sore throat, Prone position, Tracheal intubation

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.

Interventions

DRUGMagnesium Sulfate

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)

DRUGdexamethasone

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)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubationChange of post operative sore throat level from 1 to 48 hours after surgeryIncidence 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

MeasureTime frameDescription
The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubationChange of post operative sore throat level from 1 to 48 hours after surgeryIncidence 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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026